Breast Cancer Nos Metastatic RecurrentCANTONCT01993498
Chronic Toxicities Related to Treatment in Patients With Localized Cancer
A study testing blood sampling in people with Breast Cancer Nos Metastatic Recurrent and Early Lung Cancer, run by UNICANCER at 1 site in France.
Trial summary
The aims of the cohort will be to quantify impact of cancer treatments toxicities , and to generate predictors of chronic toxicity in patients with non-metastatic cancer. Study of the original cohort will be focused on localized breast cancer patients, other localisation in non-metastatic setting will be explored… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Nos Metastatic Recurrent, Early Lung Cancer
- What is being tested?
- blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,750 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2012to Mar 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women,
- Aged 18 years and over,
- With an invasive breast cancer diagnosed by cytology or histology,
- No clinical evidence of metastasis at the time of inclusion,
- Untreated including scored for breast cancer surgery in progress,
- Patient receiving a social security system,
Show all 20Show fewer
- Patient mastering the French language,
- Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage.
- (Since february 2022) Patient :
- Age < 45 years at diagnostic
- Or CT2-3, cN0-3, HER2+(RH+or RH-) or RH-HER2-
- Or Eligible to Pembrozilumab, Olaparib, TDM1, Abemaciclib or Ribociclib
- Aged 18 years and over, Having lung cancer diagnosed by cytology or histology or suspected cancer of the lung,
- Tumor cTX to cT4, cN0-3,
- No clinical evidence of metastasis at the time of inclusion (patients with metastases on extension assessment within 6 months following diagnosis will be removed from the study),
- Eligible for curative treatment by surgery or radiotherapy * (note patients treated with exclusive chemotherapy, exclusive radiotherapy or exclusive stereotactic radiotherapy will be out of study)
- Lack of treatment received for current lung cancer, including surgical treatment
- Patient benefiting from a social protection scheme,
- Patient mastering the French language,
- Free and informed consent for additional biological samples, the different questionnaires and the collection of information on resource consumption.
Who cannot join
- Metastatic breast cancer,
- Local recurrence of breast cancer,
- History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix,
- Already received treatment for breast cancer ongoing,
- Blood transfusion performed for less than six months,
- Persons deprived of liberty or under supervision (including guardianship).
Show all 13Show fewer
- CANTO - Lung
- Metastatic lung cancer,
- Local relapse of lung cancer,
- History of cancer within 3 years prior to study entry other than basal cell cutaneous or epithelioma in situ of the cervix,
- Treatment already received for current lung cancer,
- Blood transfusion carried out less than 6 months ago,
- Persons deprived of liberty or under guardianship (including curatorship).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Gustave roussy
Villejuif, 94805
Fabrice ANDRE, (0)1 42 11 43 71 ext. +33
Laetitia Shanna RAJPAR
About this study
Official title: A Prospective Cohort to Investigate Survivorship Issues in Patients With Early Cancer
The aims of the cohort will be to quantify impact of cancer treatments toxicities , and to generate predictors of chronic toxicity in patients with non-metastatic cancer. Study of the original cohort will be focused on localized breast cancer patients, other localisation in non-metastatic setting will be explored furtherwise, fist of all in lung cancer.
The project will include four specific aims :
Read more
- To develop a database of chronic treatment related toxicity in a cohort of 14750 women with stage I-III breast cancer (= non metastatic), whatever these treatments are (surgery; radiation therapy; chemotherapy …)
- To describe incidence, clinical presentation, and outcome of chronic toxicities.
- To describe the psychological, the social and the economic impacts of chronic toxicities.
- To generate predictors for chronic toxicities in order to prevent them, based upon biological criteria.
The expected impact of these toxicities, when identified, will be to improve quality of life and to decrease health cost, by the early identification of patients at high risk of toxicity. Such early identification could lead to prevent toxic effect by: a. developing prevention strategies, b. substituting toxic treatment by a non (less) toxic one.
Also, such cohort will offer a quantification of the impact of treatment toxicity, that could be further used to quantify medical usefulness of strategies that aim at decreasing treatment toxicities (implementation of predictive biomarker for resistance, cytotoxic-free regimen etc…)
Read the detailed description
SPECIFIC AIM I: TO DEVELOP A TOXICITY DATABASE ON A COHORT OF 20,000 WOMEN WITH STAGE I-III (NON METASTATIC) BREAST CANCER
Selection criteria The cohort will include female patients with non-metastatic breast cancer (stage I-III) without any selection based on their characteristics (except stage) or treatment. They may be included in other concomitant clinical studies.
Patients will have to sign informed consent and will have to benefit from social security.
The lack of selection criteria is related to the fact that the cohort aims at investigating toxicity in the whole population of breast cancer from a public health perspective.
Sample size The cohort plans to include 14750 women in 13 years. A cohort of 14750 patients will allow to detect a two fold increased in the risk of a specific toxicity in a homogenous subgroup.
As illustration, the study present a 90% power to detect whether a variable (age as example) observed in 50% of patients is associated with an increased risk of toxicity (heart toxicity) in a specific subgroup (Her2+++).
Development of the cohort The14750 patients will be recruited in 26 cancer centers, maximum in France. These patients will be followed for at least 5 years in the context of the cohort. After 5 years, additional specific data will then be captured each year.
Patients will be included at the time of diagnosis, before any cancer specific treatment. After having signed informed consent, the patient will fill a first questionnaire for demographics (adapted from French DREES reference study) and living conditions, and a set of validated questionnaires related to QoL and special psychological dimensions. In addition, blood samples will be collected at baseline.
The toxicities (events) will start to be collected 3 months after the end of "acute" treatment (surgery/adjuvant/chemotherapy/radiation therapy). Toxicity data will also be collected at the time of the last chemotherapy. Toxicities will be collected each 6 months, alternatively by a dedicated nurse and by the patient herself. Three sets of toxicities will be collected.
- First, predefined and previously described toxicities will be collected on dedicated items in the case report form.
- Second, unknown toxicities will be captured by the use of a patient's notebook where each patient will collect events and doctor' visits (general practitioner or organ specialist). This will allow capturing events that have not previously been associated with cancer treatment toxicities.
- Finally, objective measurements by paraclinic exams will be done. This includes yearly blood tests and a heart ultrasonography at 1 and 5 years.
In addition to the data collection, a baseline blood sample for genetic analyses will be done, and serum samples will be collected at baseline and yearly during 5 years (serum).
Outcome data will also be collected and will include metastatic relapse (+ site), locoregional relapse (+ site) and death.
SPECIFIC AIM II: TO DESCRIBE INCIDENCE, CLINICAL PRESENTATION, BIOLOGICAL CHARACTERISTICS AND OUTCOME OF CHRONIC TOXIC EVENTS
This specific aim will follow three goals :
- First, the investigators will describe the incidence of predefined chronic toxicities according to the treatment received.
- Second, the investigators will aim at identifying new treatment-related toxicities. This information will be captured through a dedicated notebook where each patient will report all health and social related events.
- Finally, the investigators will also assess the outcome of each adverse event, and try to develop some hypotheses to be addressed in further clinical trials.
SPECIFIC AIM III: TO DESCRIBE THE PSYCHOLOGICAL AND THE SOCIAL IMPACTS OF TOXIC EVENTS This specific aim will be split in two parts: a. to describe the psychological and the social impact to the patient, b. to describe the impact at the population level.
To describe psychological and social impact for the patient
Using robust well validated methods, subjective and objective dimensions of wellbeing will be investigated, that is: a. Quality of life b. Living conditions c. Psychosocial issues.
Quality of life Global perception of quality of life will be assessed through different survey
Social impact Living conditions will be assessed through a questionnaire derived from the French DRESS reference study on living conditions. The initial questionnaire was designed by DRESS to investigate the social, economical, professional condition two years after the diagnosis of cancer: back or abandonment of the initial professional/social activity, conversion, income trends, etc.
Psychological impact This part will focus on psychological functioning, including psychological impact of chronic toxicities and psychological impact of cancer itself. Psychological impact is mainly expected on emotional issues, cognitive disorders, body image and sexual disorders.
To describe the impact on the society This sub-aim will mainly focus on medico-economics and will assess the global impact of treatment toxicity on health economy. The quantification of costs related to toxicities is a major challenge since it could allow to identify avoidable major source of expenses and could allow better tailoring treatment accordingly. Specific partnerships are being developed with the French social security and other public/private partners in order to accurately quantify toxicity-related cost.
SPECIFIC AIM IV TO DEVELOP PREDICTORS FOR CHRONIC TOXICITIES In the present specific aim, the goal will be to develop molecular/biologic predictors for toxic events. In as many cases as possible, the investigators will split the cohort into a discovery set and a test set, or will identify a cross-validating series before doing analyses.
Ultimately, the goal is to develop multiparametric scores to predict the occurrence of toxicity.
Regarding molecular predictors, it is planned that 20 ml blood will be collected yearly. One sample at baseline will be dedicated to single nucleotide polymorphism (SNP) arrays and validation of candidate genetic variants.
A number of tests are already planned. First, we will investigate conventional biological parameters including endocrine tests (cortisolemia, TSH, estradiol levels, mullerian hormone…), metabolic test (including lipidemia), hematologic tests, liver function, immune function (assessed by lymphocyte counts). Second, more recent and under investigation tests will be added including troponin (heart failure), mullerian hormone, bone resorption markers (bone loss), RANK / RANKL, osteoprotegerin (bone loss).
Finally, it is planned to use the baseline sample for the discovery of genetic tests and to use the serum for the discovery of biochemical predictors.
- Being tested
- blood sampling
- Keywords
- cancer toxicities, cohort, breast cancer, early lung cancer
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingProcedure or surgery
blood samples collection
| Study group | Role | What they receive |
|---|---|---|
| breast cancer treatment + blood sampling | Other | Standard treatment of breast cancer with intervention : samples collection Receives: Procedure: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of chronic toxicity in patients treated for non-metastatic breast cancer
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study start20 Feb 2012
- Primary completionMar 2034 (estimated)
- Study completionMar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Nos Metastatic RecurrentStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- For each patient, in addition to standard medical follow-up collected at selection, and yearly after acute treatment cancer phase during 5 years, the CANTO-specific follow-up includes 16 patient-reported questionnaires.
- Masking
- None (open label)
- Enrolment
- 14,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inès VAZ-LUIS, Professor, Study director, Gustave Roussy - Villejuif
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993498
- Sponsor's protocol ID
- UC-0140/1103 CANTO
- Other IDs
- 2011-A01095-36
- Acronym
- CANTO
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2013
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Publications
Ruiz de Azua G, Licaj I, Ntobeng K, Havas J, Di Meglio A, Vaz-Luis I, Martin AL, Jouffroy-Zeller C, Lerebours F, Rigal O, Fournier M, Mouret-Reynier MA, Campone M, Tarpin C, Guillermet S, Giacchetti S, Petit T, Dalenc F, Dumas A, Menvielle G. Explaining educational differences in return to work after early breast cancer: a mediation analysis. J Natl Cancer Inst. 2026 Sep 29:djag350. doi: 10.1093/jnci/djag350. Online ahead of print.
PubMed 42811198Vignot S, Drouet Y, Di Meglio A, Martin AL, Gaudin C, Bertaut A, Fournier M, Jacot W, Cheymol C, Kieffer A, Tarpin C, Lerebours F, Caux C, Boyault S, Menetrier-Caux C, Tredan O. Prognostic value of lymphopenia in early breast cancer: learnings from the prospective CANTO cohort. Breast Cancer Res. 2026 Jun 9. doi: 10.1186/s13058-026-02315-7. Online ahead of print.
PubMed 42265714Ruiz De Azua G, Vaz-Luis I, Bovagnet T, Di Meglio A, Havas J, Caumette E, Martin E, Pistilli B, Coutant C, Cottu P, Rouanet P, Arnaud A, Arsene O, Ibrahim M, Wassermann J, Rouzier R, Martin AL, Everhard S, Dumas A, Menvielle G. Perceived discrimination at work: examining social, health and work-related factors as determinants among breast cancer survivors - evidence from the prospective CANTO cohort. J Epidemiol Community Health. 2022 Oct 10;76(11):918-924. doi: 10.1136/jech-2021-218331.
PubMed 41877347Bidard FC, Gessain G, Bachelot T, Frechin L, Vincent-Salomon A, Drubay D, Lemonnier J, Walter T, Penault-Llorca F, Martin AL, Gaudin C, Bichat A, Sassi F, Berlemont S, Chavez-MacGregor M, Rugo HS, Badoual C, Pistilli B, Ribeiro J, Di Meglio A, Lacroix-Triki M, Vaz Luis I, Lerousseau M, Andre F. Identifying Patients With Low Relapse Rate Despite High-Risk Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: Development and Validation of a Clinicopathologic Assay. J Clin Oncol. 2025 Oct;43(28):3090-3101. doi: 10.1200/JCO-25-00742. Epub 2025 Aug 22.
PubMed 40845255Giugliano F, Bertaut A, Blanc J, Martin AL, Gaudin C, Fournier M, Kieffer A, Sauterey B, Levy C, Campone M, Tarpin C, Lerebours F, Mouret-Reynier MA, Curigliano G, Andre F, Pistilli B, Rassy E. Characteristics, treatment patterns and survival of patients with high-risk early hormone receptor-positive breast cancer in French real-world settings: an exploratory study of the CANTO cohort. ESMO Open. 2024 Dec;9(12):103994. doi: 10.1016/j.esmoop.2024.103994. Epub 2024 Nov 28.
PubMed 39612621Pagliuca M, Havas J, Thomas E, Drouet Y, Soldato D, Franzoi MA, Ribeiro J, Chiodi CK, Gillanders E, Pistilli B, Menvielle G, Joly F, Lerebours F, Rigal O, Petit T, Giacchetti S, Dalenc F, Wassermann J, Arsene O, Martin AL, Everhard S, Tredan O, Boyault S, De Laurentiis M, Viari A, Deleuze JF, Bertaut A, Andre F, Vaz-Luis I, Di Meglio A. Long-term behavioral symptom clusters among survivors of early-stage breast cancer: Development and validation of a predictive model. J Natl Cancer Inst. 2025 Jan 1;117(1):89-102. doi: 10.1093/jnci/djae222.
PubMed 39250750Sandoval JL, Franzoi MA, di Meglio A, Ferreira AR, Viansone A, Andre F, Martin AL, Everhard S, Jouannaud C, Fournier M, Rouanet P, Vanlemmens L, Dhaini-Merimeche A, Sauterey B, Cottu P, Levy C, Stringhini S, Guessous I, Vaz-Luis I, Menvielle G. Magnitude and Temporal Variations of Socioeconomic Inequalities in the Quality of Life After Early Breast Cancer: Results From the Multicentric French CANTO Cohort. J Clin Oncol. 2024 Aug 20;42(24):2908-2917. doi: 10.1200/JCO.23.02099. Epub 2024 Jun 18.
PubMed 38889372Ruiz de Azua G, Kousignian I, Vaz-Luis I, Di Meglio A, Caumette E, Havas J, Martin E, Martin AL, Querel O, Vanlemmens L, Pistilli B, Coutant C, Cottu PH, Merimeche AD, Lerebours F, Tredan O, Jouannaud C, Levy C, Dumas A, Menvielle G. Sustainable return to work among breast cancer survivors. Cancer Med. 2023 Sep;12(18):19091-19101. doi: 10.1002/cam4.6467. Epub 2023 Aug 21.
PubMed 37602836Balazard F, Bertaut A, Bordet E, Mulard S, Blanc J, Briot N, Paux G, Dhaini Merimeche A, Rigal O, Coutant C, Fournier M, Jouannaud C, Soulie P, Lerebours F, Cottu PH, Tredan O, Vanlemmens L, Levy C, Mouret-Reynier MA, Campone M, Brady KJS, Sasane M, Rice M, Coulouvrat C, Martin AL, Jacquet A, Vaz-Luis I, Herold C, Pistilli B. Adjuvant endocrine therapy uptake, toxicity, quality of life, and prediction of early discontinuation. J Natl Cancer Inst. 2023 Sep 7;115(9):1099-1108. doi: 10.1093/jnci/djad109.
PubMed 37434306Ghannam Y, Di Meglio A, Sarrade T, Jacquet A, Everhard S, Kirova Y, Peignaux K, Guilbert P, Charra-Brunaud C, Blanchecotte J, Bochaton OF, Pasquier D, Racadot S, Bourgier C, Geffrelot J, Benyoucef A, Paris F, Auzac G, Luis IV, Rivera S. Impact of radiation therapy on fatigue at 1 year in breast cancer survivors in the prospective multicentre CANcer TOxicity cohort. Eur J Cancer. 2022 Dec;177:143-153. doi: 10.1016/j.ejca.2022.09.026. Epub 2022 Oct 10.
PubMed 36356418Soldato D, Havas J, Crane TE, Presti D, Lapidari P, Rassy N, Pistilli B, Martin E, Del Mastro L, Martin AL, Jacquet A, Coutant C, Cottu P, Merimeche A, Lerebours F, Tredan O, Vanlemmens L, Andre F, Vaz-Luis I, Di Meglio A. Coffee and tea consumption, patient-reported, and clinical outcomes in a longitudinal study of patients with breast cancer. Cancer. 2022 Oct 1;128(19):3552-3563. doi: 10.1002/cncr.34401. Epub 2022 Aug 1.
PubMed 35913436Presti D, Havas J, Soldato D, Lapidari P, Martin E, Pistilli B, Jouannaud C, Emile G, Rigal O, Fournier M, Soulie P, Mouret-Reynier MA, Tarpin C, Campone M, Guillermet S, Martin AL, Everhard S, Di Meglio A. Factors associated with enrolment in clinical trials among women with early-stage breast cancer. ESMO Open. 2022 Jun;7(3):100513. doi: 10.1016/j.esmoop.2022.100513. Epub 2022 Jun 17.
PubMed 35724624Baker JL, Di Meglio A, Gbenou AS, El Mouhebb M, Iyengar NM, Michiels S, Cottu P, Lerebours F, Coutant C, Lesur A, Tredan O, Vanlemmens L, Jouannaud C, Hrab I, Everhard S, Martin AL, Arveux P, Fabrice A, Vaz-Luis I, Jones LW. Association between physical activity and neoadjuvant chemotherapy completion and pathologic complete response in primary breast cancer: the CANTO study. Br J Cancer. 2022 Sep;127(5):886-891. doi: 10.1038/s41416-022-01870-y. Epub 2022 Jun 17.
PubMed 35715631Di Meglio A, Havas J, Gbenou AS, Martin E, El-Mouhebb M, Pistilli B, Menvielle G, Dumas A, Everhard S, Martin AL, Cottu PH, Lerebours F, Coutant C, Lesur A, Tredan O, Soulie P, Vanlemmens L, Joly F, Delaloge S, Ganz PA, Andre F, Partridge AH, Jones LW, Michiels S, Vaz-Luis I. Dynamics of Long-Term Patient-Reported Quality of Life and Health Behaviors After Adjuvant Breast Cancer Chemotherapy. J Clin Oncol. 2022 Sep 20;40(27):3190-3204. doi: 10.1200/JCO.21.00277. Epub 2022 Apr 21.
PubMed 35446677Vaz-Luis I, Di Meglio A, Havas J, El-Mouhebb M, Lapidari P, Presti D, Soldato D, Pistilli B, Dumas A, Menvielle G, Charles C, Everhard S, Martin AL, Cottu PH, Lerebours F, Coutant C, Dauchy S, Delaloge S, Lin NU, Ganz PA, Partridge AH, Andre F, Michiels S. Long-Term Longitudinal Patterns of Patient-Reported Fatigue After Breast Cancer: A Group-Based Trajectory Analysis. J Clin Oncol. 2022 Jul 1;40(19):2148-2162. doi: 10.1200/JCO.21.01958. Epub 2022 Mar 15.
PubMed 35290073
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort to Investigate Survivorship Issues in Patients With Early Cancer
- ClinicalTrials.gov ID
- NCT01993498
- Acronym / sponsor ID
- CANTO / UC-0140/1103 CANTO
- Keywords
- cancer toxicities, cohort, breast cancer, early lung cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14,750 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 20 Feb 2012 (actual)
- Primary completion
- Mar 2034 (estimated)
- Study completion
- Mar 2034 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of the cohort will be to quantify impact of cancer treatments toxicities , and to generate predictors of chronic toxicity in patients with non-metastatic cancer. Study of the original cohort will be focused on localized breast cancer patients, other localisation in non-metastatic setting will be explored furtherwise, fist of all in lung cancer.
The project will include four specific aims :
- To develop a database of chronic treatment related toxicity in a cohort of 14750 women with stage I-III breast cancer (= non metastatic), whatever these treatments are (surgery; radiation therapy; chemotherapy …)
- To describe incidence, clinical presentation, and outcome of chronic toxicities.
- To describe the psychological, the social and the economic impacts of chronic toxicities.
- To generate predictors for chronic toxicities in order to prevent them, based upon biological criteria.
The expected impact of these toxicities, when identified, will be to improve quality of life and to decrease health cost, by the early identification of patients at high risk of toxicity. Such early identification could lead to prevent toxic effect by: a. developing prevention strategies, b. substituting toxic treatment by a non (less) toxic one.
Also, such cohort will offer a quantification of the impact of treatment toxicity, that could be further used to quantify medical usefulness of strategies that aim at decreasing treatment toxicities (implementation of predictive biomarker for resistance, cytotoxic-free regimen etc…)
Detailed description
SPECIFIC AIM I: TO DEVELOP A TOXICITY DATABASE ON A COHORT OF 20,000 WOMEN WITH STAGE I-III (NON METASTATIC) BREAST CANCER
Selection criteria The cohort will include female patients with non-metastatic breast cancer (stage I-III) without any selection based on their characteristics (except stage) or treatment. They may be included in other concomitant clinical studies.
Patients will have to sign informed consent and will have to benefit from social security.
The lack of selection criteria is related to the fact that the cohort aims at investigating toxicity in the whole population of breast cancer from a public health perspective.
Sample size The cohort plans to include 14750 women in 13 years. A cohort of 14750 patients will allow to detect a two fold increased in the risk of a specific toxicity in a homogenous subgroup.
As illustration, the study present a 90% power to detect whether a variable (age as example) observed in 50% of patients is associated with an increased risk of toxicity (heart toxicity) in a specific subgroup (Her2+++).
Development of the cohort The14750 patients will be recruited in 26 cancer centers, maximum in France. These patients will be followed for at least 5 years in the context of the cohort. After 5 years, additional specific data will then be captured each year.
Patients will be included at the time of diagnosis, before any cancer specific treatment. After having signed informed consent, the patient will fill a first questionnaire for demographics (adapted from French DREES reference study) and living conditions, and a set of validated questionnaires related to QoL and special psychological dimensions. In addition, blood samples will be collected at baseline.
The toxicities (events) will start to be collected 3 months after the end of "acute" treatment (surgery/adjuvant/chemotherapy/radiation therapy). Toxicity data will also be collected at the time of the last chemotherapy. Toxicities will be collected each 6 months, alternatively by a dedicated nurse and by the patient herself. Three sets of toxicities will be collected.
- First, predefined and previously described toxicities will be collected on dedicated items in the case report form.
- Second, unknown toxicities will be captured by the use of a patient's notebook where each patient will collect events and doctor' visits (general practitioner or organ specialist). This will allow capturing events that have not previously been associated with cancer treatment toxicities.
- Finally, objective measurements by paraclinic exams will be done. This includes yearly blood tests and a heart ultrasonography at 1 and 5 years.
In addition to the data collection, a baseline blood sample for genetic analyses will be done, and serum samples will be collected at baseline and yearly during 5 years (serum).
Outcome data will also be collected and will include metastatic relapse (+ site), locoregional relapse (+ site) and death.
SPECIFIC AIM II: TO DESCRIBE INCIDENCE, CLINICAL PRESENTATION, BIOLOGICAL CHARACTERISTICS AND OUTCOME OF CHRONIC TOXIC EVENTS
This specific aim will follow three goals :
- First, the investigators will describe the incidence of predefined chronic toxicities according to the treatment received.
- Second, the investigators will aim at identifying new treatment-related toxicities. This information will be captured through a dedicated notebook where each patient will report all health and social related events.
- Finally, the investigators will also assess the outcome of each adverse event, and try to develop some hypotheses to be addressed in further clinical trials.
SPECIFIC AIM III: TO DESCRIBE THE PSYCHOLOGICAL AND THE SOCIAL IMPACTS OF TOXIC EVENTS This specific aim will be split in two parts: a. to describe the psychological and the social impact to the patient, b. to describe the impact at the population level.
To describe psychological and social impact for the patient
Using robust well validated methods, subjective and objective dimensions of wellbeing will be investigated, that is: a. Quality of life b. Living conditions c. Psychosocial issues.
Quality of life Global perception of quality of life will be assessed through different survey
Social impact Living conditions will be assessed through a questionnaire derived from the French DRESS reference study on living conditions. The initial questionnaire was designed by DRESS to investigate the social, economical, professional condition two years after the diagnosis of cancer: back or abandonment of the initial professional/social activity, conversion, income trends, etc.
Psychological impact This part will focus on psychological functioning, including psychological impact of chronic toxicities and psychological impact of cancer itself. Psychological impact is mainly expected on emotional issues, cognitive disorders, body image and sexual disorders.
To describe the impact on the society This sub-aim will mainly focus on medico-economics and will assess the global impact of treatment toxicity on health economy. The quantification of costs related to toxicities is a major challenge since it could allow to identify avoidable major source of expenses and could allow better tailoring treatment accordingly. Specific partnerships are being developed with the French social security and other public/private partners in order to accurately quantify toxicity-related cost.
SPECIFIC AIM IV TO DEVELOP PREDICTORS FOR CHRONIC TOXICITIES In the present specific aim, the goal will be to develop molecular/biologic predictors for toxic events. In as many cases as possible, the investigators will split the cohort into a discovery set and a test set, or will identify a cross-validating series before doing analyses.
Ultimately, the goal is to develop multiparametric scores to predict the occurrence of toxicity.
Regarding molecular predictors, it is planned that 20 ml blood will be collected yearly. One sample at baseline will be dedicated to single nucleotide polymorphism (SNP) arrays and validation of candidate genetic variants.
A number of tests are already planned. First, we will investigate conventional biological parameters including endocrine tests (cortisolemia, TSH, estradiol levels, mullerian hormone…), metabolic test (including lipidemia), hematologic tests, liver function, immune function (assessed by lymphocyte counts). Second, more recent and under investigation tests will be added including troponin (heart failure), mullerian hormone, bone resorption markers (bone loss), RANK / RANKL, osteoprotegerin (bone loss).
Finally, it is planned to use the baseline sample for the discovery of genetic tests and to use the serum for the discovery of biochemical predictors.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- For each patient, in addition to standard medical follow-up collected at selection, and yearly after acute treatment cancer phase during 5 years, the CANTO-specific follow-up includes 16 patient-reported questionnaires.
| Arm | Type | Receives |
|---|---|---|
| breast cancer treatment + blood sampling | Other | Procedure: blood samplingStandard treatment of breast cancer with intervention : samples collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Women,
- Aged 18 years and over,
- With an invasive breast cancer diagnosed by cytology or histology,
- No clinical evidence of metastasis at the time of inclusion,
- Untreated including scored for breast cancer surgery in progress,
Key exclusion criteria (13 listed)
- Metastatic breast cancer,
- Local recurrence of breast cancer,
- History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix,
- Already received treatment for breast cancer ongoing,
- Blood transfusion performed for less than six months,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingblood samples collection | Procedure or surgery | breast cancer treatment + blood sampling |
Primary outcome
Evaluation of chronic toxicity in patients treated for non-metastatic breast cancer
Time frame: 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Derived from this study: PubMed 42811198Ruiz de Azua G, Licaj I, Ntobeng K, Havas J, Di Meglio A, Vaz-Luis I, Martin AL, Jouffroy-Zeller C, Lerebours F, Rigal O, Fournier M, Mouret-Reynier MA, Campone M, Tarpin C, Guillermet S, Giacchetti S, Petit T, Dalenc F, Dumas A, Menvielle G. Explaining educational differences in return to work after early breast cancer: a mediation analysis. J Natl Cancer Inst. 2026 Sep 29:djag350. doi: 10.1093/jnci/djag350. Online ahead of print.
- Derived from this study: PubMed 42265714Vignot S, Drouet Y, Di Meglio A, Martin AL, Gaudin C, Bertaut A, Fournier M, Jacot W, Cheymol C, Kieffer A, Tarpin C, Lerebours F, Caux C, Boyault S, Menetrier-Caux C, Tredan O. Prognostic value of lymphopenia in early breast cancer: learnings from the prospective CANTO cohort. Breast Cancer Res. 2026 Jun 9. doi: 10.1186/s13058-026-02315-7. Online ahead of print.
- Derived from this study: PubMed 41877347Ruiz De Azua G, Vaz-Luis I, Bovagnet T, Di Meglio A, Havas J, Caumette E, Martin E, Pistilli B, Coutant C, Cottu P, Rouanet P, Arnaud A, Arsene O, Ibrahim M, Wassermann J, Rouzier R, Martin AL, Everhard S, Dumas A, Menvielle G. Perceived discrimination at work: examining social, health and work-related factors as determinants among breast cancer survivors - evidence from the prospective CANTO cohort. J Epidemiol Community Health. 2022 Oct 10;76(11):918-924. doi: 10.1136/jech-2021-218331.
- Derived from this study: PubMed 40845255Bidard FC, Gessain G, Bachelot T, Frechin L, Vincent-Salomon A, Drubay D, Lemonnier J, Walter T, Penault-Llorca F, Martin AL, Gaudin C, Bichat A, Sassi F, Berlemont S, Chavez-MacGregor M, Rugo HS, Badoual C, Pistilli B, Ribeiro J, Di Meglio A, Lacroix-Triki M, Vaz Luis I, Lerousseau M, Andre F. Identifying Patients With Low Relapse Rate Despite High-Risk Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: Development and Validation of a Clinicopathologic Assay. J Clin Oncol. 2025 Oct;43(28):3090-3101. doi: 10.1200/JCO-25-00742. Epub 2025 Aug 22.
- Derived from this study: PubMed 39612621Giugliano F, Bertaut A, Blanc J, Martin AL, Gaudin C, Fournier M, Kieffer A, Sauterey B, Levy C, Campone M, Tarpin C, Lerebours F, Mouret-Reynier MA, Curigliano G, Andre F, Pistilli B, Rassy E. Characteristics, treatment patterns and survival of patients with high-risk early hormone receptor-positive breast cancer in French real-world settings: an exploratory study of the CANTO cohort. ESMO Open. 2024 Dec;9(12):103994. doi: 10.1016/j.esmoop.2024.103994. Epub 2024 Nov 28.
- Derived from this study: PubMed 39250750Pagliuca M, Havas J, Thomas E, Drouet Y, Soldato D, Franzoi MA, Ribeiro J, Chiodi CK, Gillanders E, Pistilli B, Menvielle G, Joly F, Lerebours F, Rigal O, Petit T, Giacchetti S, Dalenc F, Wassermann J, Arsene O, Martin AL, Everhard S, Tredan O, Boyault S, De Laurentiis M, Viari A, Deleuze JF, Bertaut A, Andre F, Vaz-Luis I, Di Meglio A. Long-term behavioral symptom clusters among survivors of early-stage breast cancer: Development and validation of a predictive model. J Natl Cancer Inst. 2025 Jan 1;117(1):89-102. doi: 10.1093/jnci/djae222.
- Derived from this study: PubMed 38889372Sandoval JL, Franzoi MA, di Meglio A, Ferreira AR, Viansone A, Andre F, Martin AL, Everhard S, Jouannaud C, Fournier M, Rouanet P, Vanlemmens L, Dhaini-Merimeche A, Sauterey B, Cottu P, Levy C, Stringhini S, Guessous I, Vaz-Luis I, Menvielle G. Magnitude and Temporal Variations of Socioeconomic Inequalities in the Quality of Life After Early Breast Cancer: Results From the Multicentric French CANTO Cohort. J Clin Oncol. 2024 Aug 20;42(24):2908-2917. doi: 10.1200/JCO.23.02099. Epub 2024 Jun 18.
- Derived from this study: PubMed 37602836Ruiz de Azua G, Kousignian I, Vaz-Luis I, Di Meglio A, Caumette E, Havas J, Martin E, Martin AL, Querel O, Vanlemmens L, Pistilli B, Coutant C, Cottu PH, Merimeche AD, Lerebours F, Tredan O, Jouannaud C, Levy C, Dumas A, Menvielle G. Sustainable return to work among breast cancer survivors. Cancer Med. 2023 Sep;12(18):19091-19101. doi: 10.1002/cam4.6467. Epub 2023 Aug 21.
- Derived from this study: PubMed 37434306Balazard F, Bertaut A, Bordet E, Mulard S, Blanc J, Briot N, Paux G, Dhaini Merimeche A, Rigal O, Coutant C, Fournier M, Jouannaud C, Soulie P, Lerebours F, Cottu PH, Tredan O, Vanlemmens L, Levy C, Mouret-Reynier MA, Campone M, Brady KJS, Sasane M, Rice M, Coulouvrat C, Martin AL, Jacquet A, Vaz-Luis I, Herold C, Pistilli B. Adjuvant endocrine therapy uptake, toxicity, quality of life, and prediction of early discontinuation. J Natl Cancer Inst. 2023 Sep 7;115(9):1099-1108. doi: 10.1093/jnci/djad109.
- Derived from this study: PubMed 36356418Ghannam Y, Di Meglio A, Sarrade T, Jacquet A, Everhard S, Kirova Y, Peignaux K, Guilbert P, Charra-Brunaud C, Blanchecotte J, Bochaton OF, Pasquier D, Racadot S, Bourgier C, Geffrelot J, Benyoucef A, Paris F, Auzac G, Luis IV, Rivera S. Impact of radiation therapy on fatigue at 1 year in breast cancer survivors in the prospective multicentre CANcer TOxicity cohort. Eur J Cancer. 2022 Dec;177:143-153. doi: 10.1016/j.ejca.2022.09.026. Epub 2022 Oct 10.
- Derived from this study: PubMed 35913436Soldato D, Havas J, Crane TE, Presti D, Lapidari P, Rassy N, Pistilli B, Martin E, Del Mastro L, Martin AL, Jacquet A, Coutant C, Cottu P, Merimeche A, Lerebours F, Tredan O, Vanlemmens L, Andre F, Vaz-Luis I, Di Meglio A. Coffee and tea consumption, patient-reported, and clinical outcomes in a longitudinal study of patients with breast cancer. Cancer. 2022 Oct 1;128(19):3552-3563. doi: 10.1002/cncr.34401. Epub 2022 Aug 1.
- Derived from this study: PubMed 35724624Presti D, Havas J, Soldato D, Lapidari P, Martin E, Pistilli B, Jouannaud C, Emile G, Rigal O, Fournier M, Soulie P, Mouret-Reynier MA, Tarpin C, Campone M, Guillermet S, Martin AL, Everhard S, Di Meglio A. Factors associated with enrolment in clinical trials among women with early-stage breast cancer. ESMO Open. 2022 Jun;7(3):100513. doi: 10.1016/j.esmoop.2022.100513. Epub 2022 Jun 17.
- Individual participant dataSharing planned: Yes. Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Inès VAZ-LUIS, Professor study director
Gustave Roussy - Villejuif
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Breast Cancer Nos Metastatic Recurrent and Early Lung Cancer, run by UNICANCER at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Gaudin ((0)6 71 48 27 76 ext. + 33, c-gaudin@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of chronic toxicity in patients treated for non-metastatic breast cancer (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01993498, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.