Metastatic Breast CancerAMBRANCT02365831
Observation of Medical Treatments in MBC HER2-negative Patients
An observational study of Metastatic Breast Cancer, run by Consorzio Oncotech at 1 site in Italy.
Trial summary
While therapeutic strategies for HER2-positive breast cancer are well defined, there is not a standard strategy for HER2-negative tumors. Because of lack of information related to the the factors affecting the choice of a particular treatment strategy, as well as the optimization of the correct sequence of treatments… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Observation of treatment management
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- May 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Female patients from Italy with metastatic breast cancer.
Who may be able to join
- Patients with HER2-negative metastatic breast cancer (Stage IV), that have received or not the endocrine therapy for the metastatic disease and that are candidate for the first-line chemotherapy treatment in the years 2014-2015 (prospective cohort), or patients that have received a treatment of first, second or subsequent-line of chemotherapy for the metastatic disease in the years 2012-2013 (retrospective cohort).
- Age > 18 years
- Availability of all information required by the study, in particular:
- histology
- hormone receptor status
- grading
Show all 14Show fewer
- stage of disease at diagnosis
- type of surgery for the primary tumor
- type of adjuvant therapy (chemotherapy or hormone therapy)
- type of medication received as adjuvant therapy
- date and seat of the relapse
- type of treatment received for the first / second / third-line of treatment of metastatic disease (chemotherapy or hormone therapy)
- type of chemotherapy regimen used and details about the medication, date and seat of disease progression
- Written informed consent (in case of the impossibility to obtain the consent in writing, eg, death of the patient, the data will be collected as required by the Guarantor, OJ N.72 of March 26, 2012)
Who cannot join
- Patients with metastatic disease at diagnosis
- Patients with HER2-positive breast
- Participation in clinical research protocols, both for the retrospective cohort and for the perspective one
Trial locations and contacts
1 site in 1 country.
MD contact
Italy1 site, 1 recruiting
- Recruiting
A.O. San Gerardo
Monza, 20900
Marina Elena Cazzaniga, MD, 039-233.3683, ricercaindipendente.monza@gmail.com
Marina Elena Cazzaniga, MD
About this study
Official title: Evaluation of Medical Treatments in MBC HER2 Negative Patients in Italy - Observational Study
While therapeutic strategies for HER2-positive breast cancer are well defined, there is not a standard strategy for HER2-negative tumors.
Because of lack of information related to the the factors affecting the choice of a particular treatment strategy, as well as the optimization of the correct sequence of treatments, the choice of the treatment for the advanced disease remains highly empirical and may differ significantly among the different cancer centers.
Read more
The purpose of this study is the observation of a cohort of patients with metastatic HER2-negative in terms of:
- the choice of chemotherapy treatments starting from the first line of treatment;
- factors that may influence these choices;
- correlation among the characteristics of patients (age, menopausal status, etc.) and type of adjuvant and metastatic treatment ;
- clinical outcome (pattern of relapse, time from diagnosis, etc.);
- evaluation of the adherence to the literature's recommendations for therapeutic sequences in clinical practice.
Read the detailed description
In particular, the attention will be on those factors, largely discussed in the literature, that predominantly guide the choice among different therapeutic approaches such as:
- metastatic sites;
- hormone receptor status;
- disease-free interval;
- grading;
- response to a previous treatment with hormonal therapy or chemotherapy. The primary objective is the description of medical therapeutic strategies for the first, the second and the subsequent lines of chemotherapy in a cohort of patients with HER2-negative metastatic breast cancer and the evaluation of the possible correlation between the choice of treatment, in the adjuvant phase or for the metastatic disease and also for the patients' characteristics (age, menopausal status, comorbidity). the secondary objectives are:
- Analyze the "Time to Treatment Change", defined as the interval of time that elapses from the start of chemotherapy to the discontinuation or the occurrence of any other event. This finding is of a particular clinical relevance, since randomized trials using the "Time To Progression" (TTP) as a measure of effectiveness of the treatment in the study, but this time parameter may not correspond to what is observed in clinical practice, where the revaluations of disease are not conducted at preset intervals as is in the case of controlled clinical trials.
- Evaluate the correlation between the characteristics of the patients and the choice of the type of chemotherapy.
- Assess the potential correlation between the type of adjuvant therapy and the type of response obtained with the first-line treatment and between the answer to this last therapy line and second/third one.
- Assess the adherence to the literature's recommendations (Consensus Conferences and Guide-lines) of the choices between the sequential therapy vs the combination therapy in different lines of treatment (first, second, third line) of the metastatic disease.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Observation of treatment management
- Keywords
- MBC, breast, metastatic, cancer, HER2
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of treatment managementOther
Group/cohort
| Study group | Role | What they receive |
|---|---|---|
| Prospective | Observation of treatment management of patients with metastatic breast cancer that have been treated or not with hormonal therapy and candidate for a first line chemotherapeutic treatment in the years 2014-2015 will be observed until the end of the study. Receives: Other: Observation of treatment management | |
| Retrospective | Observation of treatment management of patients with metastatic breast cancer that have been treated with a first, second or following line of chemotherapeutic treatment for metastatic disease in the years 2012-2013. Receives: Other: Observation of treatment management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number subsequent lines of treatment.
Evaluation of correlation between treatment choice and patient characteristic ( age, menopausal status, comorbidity).
Measured: Outcome 1 assessed up to 24 months (2012 until 2016 where applicable)
Secondary outcomes (3)
Time to Treatment Change
evaluation of the time interval between the begin of chemotherapic treatment and its interruption.
Measured: Outcome 2 assessed up to 24 months (2012 until 2016 where applicable)
Correlation between the type of adjuvant therapy and the type of response to the treatment
Measured: Outcome 3 assessed up to 24 months (2012 until 2016 where applicable)
Evaluation of the adherence to the Consensus Conferences and Guidelines concerning the choice between the sequential therapies versus the combination therapies ( first, second, third line)
Measured: Outcome 4 assessed up to 24 months (2012 until 2016 where applicable)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorzio Oncotech
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Research Technology S.r.l.
- Responsible party
- Sponsor
- Investigators
- Marina Cazzaniga, MD, Principal investigator, Azienda Ospedaliera San Gerardo-Oncologia Medica (Saint Gerard Hospital-Medical Oncology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365831
- Sponsor's protocol ID
- GIM13-AMBRA
- Acronym
- AMBRA
- Status last verified
- Jun 2016
- First submitted
- 15 Dec 2014
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Perez EA, Suman VJ, Davidson NE, Gralow JR, Kaufman PA, Visscher DW, Chen B, Ingle JN, Dakhil SR, Zujewski J, Moreno-Aspitia A, Pisansky TM, Jenkins RB. Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer. J Clin Oncol. 2011 Dec 1;29(34):4491-7. doi: 10.1200/JCO.2011.36.7045. Epub 2011 Oct 31.
PubMed 22042958Cazzaniga ME, Mustacchi G, Pronzato P, De Matteis A, Di Costanzo F, Floriani I; NORA Study Group. Adjuvant systemic treatment of early breast cancer: the NORA study. Ann Oncol. 2006 Sep;17(9):1386-92. doi: 10.1093/annonc/mdl132. Epub 2006 Jun 21.
PubMed 16790520Smith I, Procter M, Gelber RD, Guillaume S, Feyereislova A, Dowsett M, Goldhirsch A, Untch M, Mariani G, Baselga J, Kaufmann M, Cameron D, Bell R, Bergh J, Coleman R, Wardley A, Harbeck N, Lopez RI, Mallmann P, Gelmon K, Wilcken N, Wist E, Sanchez Rovira P, Piccart-Gebhart MJ; HERA study team. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet. 2007 Jan 6;369(9555):29-36. doi: 10.1016/S0140-6736(07)60028-2.
PubMed 17208639O'Shaughnessy JA, Brufsky AM. RiBBON 1 and RiBBON 2: phase III trials of bevacizumab with standard chemotherapy for metastatic breast cancer. Clin Breast Cancer. 2008 Aug;8(4):370-3. doi: 10.3816/CBC.2008.n.045. No abstract available.
PubMed 18757267Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. doi: 10.1056/NEJMoa0910383.
PubMed 21991949Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, Gianni L, Baselga J, Bell R, Jackisch C, Cameron D, Dowsett M, Barrios CH, Steger G, Huang CS, Andersson M, Inbar M, Lichinitser M, Lang I, Nitz U, Iwata H, Thomssen C, Lohrisch C, Suter TM, Ruschoff J, Suto T, Greatorex V, Ward C, Straehle C, McFadden E, Dolci MS, Gelber RD; Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1659-72. doi: 10.1056/NEJMoa052306.
PubMed 16236737Gianni L, Dafni U, Gelber RD, Azambuja E, Muehlbauer S, Goldhirsch A, Untch M, Smith I, Baselga J, Jackisch C, Cameron D, Mano M, Pedrini JL, Veronesi A, Mendiola C, Pluzanska A, Semiglazov V, Vrdoljak E, Eckart MJ, Shen Z, Skiadopoulos G, Procter M, Pritchard KI, Piccart-Gebhart MJ, Bell R; Herceptin Adjuvant (HERA) Trial Study Team. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol. 2011 Mar;12(3):236-44. doi: 10.1016/S1470-2045(11)70033-X. Epub 2011 Feb 25.
PubMed 21354370Clavarezza M, Mustacchi G, Casadei Gardini A, Del Mastro L, De Matteis A, Riccardi F, Adamo V, Aitini E, Amoroso D, Marchetti P, Gori S, Carrozza F, Maiello E, Giotta F, Dondi D, Venturini M. Biological characterization and selection criteria of adjuvant chemotherapy for early breast cancer: experience from the Italian observational NEMESI study. BMC Cancer. 2012 Jun 6;12:216. doi: 10.1186/1471-2407-12-216.
PubMed 22672524Gennari A, Stockler M, Puntoni M, Sormani M, Nanni O, Amadori D, Wilcken N, D'Amico M, DeCensi A, Bruzzi P. Duration of chemotherapy for metastatic breast cancer: a systematic review and meta-analysis of randomized clinical trials. J Clin Oncol. 2011 Jun 1;29(16):2144-9. doi: 10.1200/JCO.2010.31.5374. Epub 2011 Apr 4.
PubMed 21464403Kennecke H, Yerushalmi R, Woods R, Cheang MC, Voduc D, Speers CH, Nielsen TO, Gelmon K. Metastatic behavior of breast cancer subtypes. J Clin Oncol. 2010 Jul 10;28(20):3271-7. doi: 10.1200/JCO.2009.25.9820. Epub 2010 May 24.
PubMed 20498394Arvold ND, Taghian AG, Niemierko A, Abi Raad RF, Sreedhara M, Nguyen PL, Bellon JR, Wong JS, Smith BL, Harris JR. Age, breast cancer subtype approximation, and local recurrence after breast-conserving therapy. J Clin Oncol. 2011 Oct 10;29(29):3885-91. doi: 10.1200/JCO.2011.36.1105. Epub 2011 Sep 6.
PubMed 21900114Beslija S, Bonneterre J, Burstein HJ, Cocquyt V, Gnant M, Heinemann V, Jassem J, Kostler WJ, Krainer M, Menard S, Petit T, Petruzelka L, Possinger K, Schmid P, Stadtmauer E, Stockler M, Van Belle S, Vogel C, Wilcken N, Wiltschke C, Zielinski CC, Zwierzina H; Central European Cooperative Oncology Group (CECOG). Third consensus on medical treatment of metastatic breast cancer. Ann Oncol. 2009 Nov;20(11):1771-85. doi: 10.1093/annonc/mdp261. Epub 2009 Jul 16.
PubMed 19608616Cazzaniga M, Pronzato P, Leto di Priolo SL, De Matteis A, Di Costanzo F, Passalacqua R, Rosso R, Torri V. Patterns of relapse and modalities of treatment of breast cancer: the 'IRIS' Project, a multicenter observational study. Oncology. 2004;66(4):260-8. doi: 10.1159/000078325.
PubMed 15218292Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998 Apr 30;17(8):857-72. doi: 10.1002/(sici)1097-0258(19980430)17:83.0.co;2-e.
PubMed 9595616
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Medical Treatments in MBC HER2 Negative Patients in Italy - Observational Study
- ClinicalTrials.gov ID
- NCT02365831
- Acronym / sponsor ID
- AMBRA / GIM13-AMBRA
- Conditions
- Metastatic Breast Cancer
- Keywords
- MBC, breast, metastatic, cancer, HER2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Consorzio OncotechUniversity, hospital or other
- Collaborators
- Clinical Research Technology S.r.l.
- Study start
- May 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 Feb 2015 (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.
While therapeutic strategies for HER2-positive breast cancer are well defined, there is not a standard strategy for HER2-negative tumors.
Because of lack of information related to the the factors affecting the choice of a particular treatment strategy, as well as the optimization of the correct sequence of treatments, the choice of the treatment for the advanced disease remains highly empirical and may differ significantly among the different cancer centers.
The purpose of this study is the observation of a cohort of patients with metastatic HER2-negative in terms of:
- the choice of chemotherapy treatments starting from the first line of treatment;
- factors that may influence these choices;
- correlation among the characteristics of patients (age, menopausal status, etc.) and type of adjuvant and metastatic treatment ;
- clinical outcome (pattern of relapse, time from diagnosis, etc.);
- evaluation of the adherence to the literature's recommendations for therapeutic sequences in clinical practice.
Detailed description
In particular, the attention will be on those factors, largely discussed in the literature, that predominantly guide the choice among different therapeutic approaches such as:
- metastatic sites;
- hormone receptor status;
- disease-free interval;
- grading;
- response to a previous treatment with hormonal therapy or chemotherapy. The primary objective is the description of medical therapeutic strategies for the first, the second and the subsequent lines of chemotherapy in a cohort of patients with HER2-negative metastatic breast cancer and the evaluation of the possible correlation between the choice of treatment, in the adjuvant phase or for the metastatic disease and also for the patients' characteristics (age, menopausal status, comorbidity). the secondary objectives are:
- Analyze the "Time to Treatment Change", defined as the interval of time that elapses from the start of chemotherapy to the discontinuation or the occurrence of any other event. This finding is of a particular clinical relevance, since randomized trials using the "Time To Progression" (TTP) as a measure of effectiveness of the treatment in the study, but this time parameter may not correspond to what is observed in clinical practice, where the revaluations of disease are not conducted at preset intervals as is in the case of controlled clinical trials.
- Evaluate the correlation between the characteristics of the patients and the choice of the type of chemotherapy.
- Assess the potential correlation between the type of adjuvant therapy and the type of response obtained with the first-line treatment and between the answer to this last therapy line and second/third one.
- Assess the adherence to the literature's recommendations (Consensus Conferences and Guide-lines) of the choices between the sequential therapy vs the combination therapy in different lines of treatment (first, second, third line) of the metastatic disease.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective | – | Other: Observation of treatment managementObservation of treatment management of patients with metastatic breast cancer that have been treated or not with hormonal therapy and candidate for a first line chemotherapeutic treatment in the years 2014-2015 will be observed until the end of the study. |
| Retrospective | – | Other: Observation of treatment managementObservation of treatment management of patients with metastatic breast cancer that have been treated with a first, second or following line of chemotherapeutic treatment for metastatic disease in the years 2012-2013. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients from Italy with metastatic breast cancer.
Key inclusion criteria (14 listed)
- Patients with HER2-negative metastatic breast cancer (Stage IV), that have received or not the endocrine therapy for the metastatic disease and that are candidate for the first-line chemotherapy treatment in the years 2014-2015 (prospective cohort), or patients that have received a treatment of first, second or subsequent-line of chemotherapy for the metastatic disease in the years 2012-2013 (retrospective cohort).
- Age > 18 years
- Availability of all information required by the study, in particular:
- Written informed consent (in case of the impossibility to obtain the consent in writing, eg, death of the patient, the data will be collected as required by the Guarantor, OJ N.72 of March 26, 2012)
Key exclusion criteria (3 listed)
- Patients with metastatic disease at diagnosis
- Patients with HER2-positive breast
- Participation in clinical research protocols, both for the retrospective cohort and for the perspective one
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 |
|---|---|---|
| Observation of treatment managementGroup/cohort | Other | Prospective, Retrospective |
Primary outcome
Number subsequent lines of treatment.
Time frame: Outcome 1 assessed up to 24 months (2012 until 2016 where applicable)
Evaluation of correlation between treatment choice and patient characteristic ( age, menopausal status, comorbidity).
3 secondary outcomes
Time to Treatment Change
Time frame: Outcome 2 assessed up to 24 months (2012 until 2016 where applicable)
Correlation between the type of adjuvant therapy and the type of response to the treatment
Time frame: Outcome 3 assessed up to 24 months (2012 until 2016 where applicable)
Evaluation of the adherence to the Consensus Conferences and Guidelines concerning the choice between the sequential therapies versus the combination therapies ( first, second, third line)
Time frame: Outcome 4 assessed up to 24 months (2012 until 2016 where applicable)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
- Background: PubMed 22042958Perez EA, Suman VJ, Davidson NE, Gralow JR, Kaufman PA, Visscher DW, Chen B, Ingle JN, Dakhil SR, Zujewski J, Moreno-Aspitia A, Pisansky TM, Jenkins RB. Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer. J Clin Oncol. 2011 Dec 1;29(34):4491-7. doi: 10.1200/JCO.2011.36.7045. Epub 2011 Oct 31.
- Background: PubMed 16790520Cazzaniga ME, Mustacchi G, Pronzato P, De Matteis A, Di Costanzo F, Floriani I; NORA Study Group. Adjuvant systemic treatment of early breast cancer: the NORA study. Ann Oncol. 2006 Sep;17(9):1386-92. doi: 10.1093/annonc/mdl132. Epub 2006 Jun 21.
- Background: PubMed 17208639Smith I, Procter M, Gelber RD, Guillaume S, Feyereislova A, Dowsett M, Goldhirsch A, Untch M, Mariani G, Baselga J, Kaufmann M, Cameron D, Bell R, Bergh J, Coleman R, Wardley A, Harbeck N, Lopez RI, Mallmann P, Gelmon K, Wilcken N, Wist E, Sanchez Rovira P, Piccart-Gebhart MJ; HERA study team. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet. 2007 Jan 6;369(9555):29-36. doi: 10.1016/S0140-6736(07)60028-2.
- Results publication: PubMed 18757267O'Shaughnessy JA, Brufsky AM. RiBBON 1 and RiBBON 2: phase III trials of bevacizumab with standard chemotherapy for metastatic breast cancer. Clin Breast Cancer. 2008 Aug;8(4):370-3. doi: 10.3816/CBC.2008.n.045. No abstract available.
- Results publication: PubMed 21991949Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. doi: 10.1056/NEJMoa0910383.
- Results publication: PubMed 16236737Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, Gianni L, Baselga J, Bell R, Jackisch C, Cameron D, Dowsett M, Barrios CH, Steger G, Huang CS, Andersson M, Inbar M, Lichinitser M, Lang I, Nitz U, Iwata H, Thomssen C, Lohrisch C, Suter TM, Ruschoff J, Suto T, Greatorex V, Ward C, Straehle C, McFadden E, Dolci MS, Gelber RD; Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1659-72. doi: 10.1056/NEJMoa052306.
- Results publication: PubMed 21354370Gianni L, Dafni U, Gelber RD, Azambuja E, Muehlbauer S, Goldhirsch A, Untch M, Smith I, Baselga J, Jackisch C, Cameron D, Mano M, Pedrini JL, Veronesi A, Mendiola C, Pluzanska A, Semiglazov V, Vrdoljak E, Eckart MJ, Shen Z, Skiadopoulos G, Procter M, Pritchard KI, Piccart-Gebhart MJ, Bell R; Herceptin Adjuvant (HERA) Trial Study Team. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol. 2011 Mar;12(3):236-44. doi: 10.1016/S1470-2045(11)70033-X. Epub 2011 Feb 25.
- Results publication: PubMed 22672524Clavarezza M, Mustacchi G, Casadei Gardini A, Del Mastro L, De Matteis A, Riccardi F, Adamo V, Aitini E, Amoroso D, Marchetti P, Gori S, Carrozza F, Maiello E, Giotta F, Dondi D, Venturini M. Biological characterization and selection criteria of adjuvant chemotherapy for early breast cancer: experience from the Italian observational NEMESI study. BMC Cancer. 2012 Jun 6;12:216. doi: 10.1186/1471-2407-12-216.
- Results publication: PubMed 21464403Gennari A, Stockler M, Puntoni M, Sormani M, Nanni O, Amadori D, Wilcken N, D'Amico M, DeCensi A, Bruzzi P. Duration of chemotherapy for metastatic breast cancer: a systematic review and meta-analysis of randomized clinical trials. J Clin Oncol. 2011 Jun 1;29(16):2144-9. doi: 10.1200/JCO.2010.31.5374. Epub 2011 Apr 4.
- Results publication: PubMed 20498394Kennecke H, Yerushalmi R, Woods R, Cheang MC, Voduc D, Speers CH, Nielsen TO, Gelmon K. Metastatic behavior of breast cancer subtypes. J Clin Oncol. 2010 Jul 10;28(20):3271-7. doi: 10.1200/JCO.2009.25.9820. Epub 2010 May 24.
- Results publication: PubMed 21900114Arvold ND, Taghian AG, Niemierko A, Abi Raad RF, Sreedhara M, Nguyen PL, Bellon JR, Wong JS, Smith BL, Harris JR. Age, breast cancer subtype approximation, and local recurrence after breast-conserving therapy. J Clin Oncol. 2011 Oct 10;29(29):3885-91. doi: 10.1200/JCO.2011.36.1105. Epub 2011 Sep 6.
- Results publication: PubMed 19608616Beslija S, Bonneterre J, Burstein HJ, Cocquyt V, Gnant M, Heinemann V, Jassem J, Kostler WJ, Krainer M, Menard S, Petit T, Petruzelka L, Possinger K, Schmid P, Stadtmauer E, Stockler M, Van Belle S, Vogel C, Wilcken N, Wiltschke C, Zielinski CC, Zwierzina H; Central European Cooperative Oncology Group (CECOG). Third consensus on medical treatment of metastatic breast cancer. Ann Oncol. 2009 Nov;20(11):1771-85. doi: 10.1093/annonc/mdp261. Epub 2009 Jul 16.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
MD contact
Marina Cazzaniga, MD principal investigator
Azienda Ospedaliera San Gerardo-Oncologia Medica (Saint Gerard Hospital-Medical Oncology)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Consorzio Oncotech at 1 site in Italy.
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 14 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Jun 2016. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MD, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number subsequent lines of treatment. (time frame: Outcome 1 assessed up to 24 months (2012 until 2016 where applicable)). 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 NCT02365831, which also lists 14 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 15 Jun 2016.