Ductal Carcinoma in SituPhase 2HORNEO01NCT04666961
Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
A Phase 2 study testing Tamoxifen 20 mg and Anastrozole 1Mg Tab in people with Ductal Carcinoma in Situ and Extensive Disease, run by Institut Cancerologie de l'Ouest at 8 sites in France.
Trial summary
Ductal carcinoma in situ (DCIS) accounts for approximately 20% of newly diagnosed breast cancer cases. Of these women, 20% require radical management in the form of mastectomy because of the extent of the lesions, which most often manifest as diffuse microcalcifications. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Ductal Carcinoma in Situ, Extensive Disease, Mastectomy
- What is being tested?
- Tamoxifen 20 mg and Anastrozole 1Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 8 sitesFrance
- Study dates
- 3 Feb 2021to 1 Aug 2033
- Phase
- Phase 2
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 40 years old
- Histological diagnosis of ductal carcinoma in situ without infiltrating contingent
- Clinical T0N0
- Estrogen receptor positive (OR+) regardless of progesterone receptor (PR) status
- Indication for mastectomy
- DCIS visible on MRI performed with clip sequence
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- Effective contraceptive method for women of childbearing age who are sexually active and who have reported sexual activity.
- Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator.
- Affiliated patient or beneficiary of the social security system.
Who cannot join
- Invasive breast carcinoma
- Lobular carcinoma in situ
- pN+ patient
- Indication for conservative surgery
- Contraindications to anastrozole or tamoxifen
- Concomitant treatments that may interact and reduce the efficacy of tamoxifen by interaction with cytochrome CYP2D6.
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- Histologically proven multifocal lesion
- Contraindication to breast MRI (pace maker, heart valve, metallic implant, neuronal or peripheral stimulator, severe claustrophobia, ...)
- History of homolateral breast cancer
- Ongoing contralateral breast cancer
- Known mutation BRCA1 BRCA2
- Other cancer in progress at inclusion
- Pregnant woman, or breastfeeding,
- Persons deprived of liberty or under guardianship or trusteeship,
- Impossibility to undergo the medical follow-up of the trial for geographical, social, psychic or psychiatric reasons.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
ICO - Site Paul Papin
Angers, 49055
Augustin P REYNARD, MD, augustin.reynard@ico.unicancer.fr
Sandrine HIRET, MD
- Recruiting
Institut Bergonie
Bordeaux, 33076
Sophie AURIOL-LEIZAGOYEN, MD, s.auriol@bordeaux.unicancer.fr
Sophie AURIOL-LEIZAGOYEN, MD
- Recruiting
Institut de cancérologie de Montpellier
Montpellier, 34298
Marian GUTOWSKI, MD, marian.gutowski@icm.unicancer.fr
- Recruiting
Centre Antoine Lacassagne
Nice, 06189
Marie GOSSET, MD, marie.gosset@nice.unicancer.fr
- Not yet recruiting
Institut Curie - Site de Paris
Paris, 75005
Enora LAAS, MD, enora.laas@curie.fr
Enora LAAS, MD
- Recruiting
Hopital Saint Joseph
Paris, 75014
Séverine ALRAN, MD, Salran@hpsj.fr
Séverine ALRAN, MD
- Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
Victoire BRILLAUD-MEFLAH, MD, Victoire.brillaud-meflah@ico.unicancer.fr
Victoire BRILLAUD-MEFLAH, MD
- Recruiting
IUCT-O
Toulouse, 31059
Gabrielle SELMES, MD, selmes.gabrielle@iuct-oncopole.fr
Gabrielle SELMES
About this study
Ductal carcinoma in situ (DCIS) accounts for approximately 20% of newly diagnosed breast cancer cases. Of these women, 20% require radical management in the form of mastectomy because of the extent of the lesions, which most often manifest as diffuse microcalcifications.
This mutilating surgical management contrasts with the excellent prognosis of this pathology and considerably alters the quality of life of patients.
Read more
Neoadjuvant hormone therapy has shown its efficacy in hormone-dependent infiltrating ductal carcinomas and offers the possibility of conservative surgery after hormone therapy.
Adjuvant hormone therapy with Tamoxifen or anti-aromatase drugs has shown its efficacy in the prevention of homo or contralateral recurrence.
The HORNEO 01 trial fits perfectly in the current context of surgical de-escalation of ductal carcinomas in situ. The objective of the study is to evaluate the impact of neoadjuvant hormone therapy on the surgical management of extensive DCIS.
Read the detailed description
Description of the modalities for recruiting :
Following screening and discovery of a DCIS, patients are referred to the center for surgical management.
During a standard consultation, the surgeon presents the study to the patient who has been diagnosed with extensive DCIS with an indication for mastectomy. The surgeon provides the patient with the information note and the consent form to participate in the study. Once the consent form is signed by the patient and the investigator, the investigator prescribes a screening test to be performed within 30 days prior to the start of hormone therapy.
Screening assessment includes :
A clinical exam and a breast imaging exam (mammography and breast and axillary ultrasound). In case of a suspicious breast ultrasound image, microbiopsy will be performed to eliminate an infiltrating component.
One or more macrobiopsy. Each biopsied site will be located using an X-ray clip inserted at the time of sample.
A MRI post-macrobiopsy. Research of estrogen receptor expression
Once the investigator has verified and validated all the eligibility criteria, the patient will be included.
Prescriptions for Tamoxifen (non-menopausal patients) or Anastrozole (menopausal patients) are given to patients and dispensed by the center's pharmacy.
Monitoring during treatment :
Patients will benefit from imaging monitoring (Mammography, +/- breast ultrasound, +/- axillary ultrasound, MRI) at 3 months and 6 months during hormonotherapy.
In case of progression observed during treatment, hormone therapy will be stopped and you will then benefit from a mastectomy.
Surgery :
Mastectomy or tumorectomy will be performed according to the tumor response to hormone therapy observed on MRI.
All patients will benefit sentinel node detection. An additional axillary dissection will be performed based on the results of the sentinel node analysis.
Analysis of biomarkers and tumor microenvironment before and after treatment on diagnostic macrobiopsies and on tumorectomy or mastectomy will be performed at Institut de Cancérologie de l'Ouest.
Patients will be seen in postoperative consultation. Adjuvant treatments or re-surgical interventions will be prescribed, carried out, and the patients will be followed up and examined at 6 months after surgery or at the end of adjuvant treatments and then annually for 10 years (with control mammography).
Patients who have had conservative surgery will have an MRI at 6 months from the end of radiotherapy.
All patients will be asked to complete quality of life questionnaires at baseline, 6 and 12 months post-surgery, and annually for 9 years:
EORTC QLQ-C30 (up to 5 years only), Short Form (36) Health Survey questionnaire.
- Conditions
- Ductal Carcinoma in Situ, Extensive Disease, Mastectomy
- Being tested
- Tamoxifen 20 mg, Anastrozole 1Mg Tab
- Keywords
- Neoadjuvant hormonotherapy, Tamoxifen, Anastrozole, conservative surgery, Breast cancer, extensive microcalcifications
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamoxifen 20 mgDrug
Tamoxifen will be initiated in non menopausal patients orally for 6 months in a neoadjuvant situation.
Anastrozole 1Mg TabDrug
Anastrozole will be initiated in menopausal patients orally for 6 months in a neoadjuvant situation.
| Study group | Role | What they receive |
|---|---|---|
| Extended ductal carcinoma in situ with mastectomy indication | Experimental | Patients receive 6 months of tamoxifen or anastrozole in a neoadjuvant situation.
Tamoxifen and Anastrozole will be delivered in their original packaging at J0 and M3 :
* Tamoxifen: box of tablets dosed at 20 mg
* Anastrozole: box of tablets 1 mg. Tamoxifen will be initiated in premenopausal patients orally at a standard dose of 20mg/day as a single dose for 6 months.
Anastrozole will be administered orally to postmenopausal patients at the standard dose of 1mg/day in a single dose for 6 months. Receives: Drug: Tamoxifen 20 mg; Drug: Anastrozole 1Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of neoadjuvant hormonotherapy
% of conservative surgeries performed after hormonotherapy
Measured: 6 months of hormonotherapy
Secondary outcomes (6)
Disease-free survival (DFS)
DFS rates at 5 and 10 years post-surgery
Measured: 5 and 10 years post-surgery
Overall survival (OS)
Survival rates at 5 and 10 years post-surgery
Measured: 5 and 10 years post-surgery
Pathologic Complete Response (pCR)
Pathologic complete response is defined as no residual invasive cancer in the surgical specimen
Measured: 6 months of hormonotherapy
Predictive factors of response
Response is defined by the variation in the diameter of the longest dimension of the target lesion measured by MRI
Measured: 3 and 6 months of hormonotherapy
Quality of Life (Qol)
EORTC QLQ-C30 questionnaire
Measured: At baseline, at 6 months and 12 months post-surgery, and then each year for 4 years
Quality of Life (Qol)
SF-36 questionnaire
Measured: At baseline, at 6 months and 12 months post-surgery, and then each year for 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start3 Feb 2021
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Carcinoma in SituStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with extensive ductal carcinoma in situ with an indication for mastectomy receiving neoadjuvant hormone therapy with Tamoxifen (non-menopausal patients) or Anastrozole (postmenopausal patients)
- Masking
- None (open label)
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoire BRILLAUD-MEFLAH, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666961
- Sponsor's protocol ID
- ICO-2020-06
- Acronym
- HORNEO01
- Status last verified
- Apr 2022
- First submitted
- 2 Dec 2020
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
- ClinicalTrials.gov ID
- NCT04666961
- Acronym / sponsor ID
- HORNEO01 / ICO-2020-06
- Conditions
- Ductal Carcinoma in Situ, Extensive Disease, Mastectomy
- Keywords
- Neoadjuvant hormonotherapy, Tamoxifen, Anastrozole, conservative surgery, Breast cancer, extensive microcalcifications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2033 (estimated)
- First posted
- 14 Dec 2020 (actual)
- 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.
Ductal carcinoma in situ (DCIS) accounts for approximately 20% of newly diagnosed breast cancer cases. Of these women, 20% require radical management in the form of mastectomy because of the extent of the lesions, which most often manifest as diffuse microcalcifications.
This mutilating surgical management contrasts with the excellent prognosis of this pathology and considerably alters the quality of life of patients.
Neoadjuvant hormone therapy has shown its efficacy in hormone-dependent infiltrating ductal carcinomas and offers the possibility of conservative surgery after hormone therapy.
Adjuvant hormone therapy with Tamoxifen or anti-aromatase drugs has shown its efficacy in the prevention of homo or contralateral recurrence.
The HORNEO 01 trial fits perfectly in the current context of surgical de-escalation of ductal carcinomas in situ. The objective of the study is to evaluate the impact of neoadjuvant hormone therapy on the surgical management of extensive DCIS.
Detailed description
Description of the modalities for recruiting :
Following screening and discovery of a DCIS, patients are referred to the center for surgical management.
During a standard consultation, the surgeon presents the study to the patient who has been diagnosed with extensive DCIS with an indication for mastectomy. The surgeon provides the patient with the information note and the consent form to participate in the study. Once the consent form is signed by the patient and the investigator, the investigator prescribes a screening test to be performed within 30 days prior to the start of hormone therapy.
Screening assessment includes :
A clinical exam and a breast imaging exam (mammography and breast and axillary ultrasound). In case of a suspicious breast ultrasound image, microbiopsy will be performed to eliminate an infiltrating component.
One or more macrobiopsy. Each biopsied site will be located using an X-ray clip inserted at the time of sample.
A MRI post-macrobiopsy. Research of estrogen receptor expression
Once the investigator has verified and validated all the eligibility criteria, the patient will be included.
Prescriptions for Tamoxifen (non-menopausal patients) or Anastrozole (menopausal patients) are given to patients and dispensed by the center's pharmacy.
Monitoring during treatment :
Patients will benefit from imaging monitoring (Mammography, +/- breast ultrasound, +/- axillary ultrasound, MRI) at 3 months and 6 months during hormonotherapy.
In case of progression observed during treatment, hormone therapy will be stopped and you will then benefit from a mastectomy.
Surgery :
Mastectomy or tumorectomy will be performed according to the tumor response to hormone therapy observed on MRI.
All patients will benefit sentinel node detection. An additional axillary dissection will be performed based on the results of the sentinel node analysis.
Analysis of biomarkers and tumor microenvironment before and after treatment on diagnostic macrobiopsies and on tumorectomy or mastectomy will be performed at Institut de Cancérologie de l'Ouest.
Patients will be seen in postoperative consultation. Adjuvant treatments or re-surgical interventions will be prescribed, carried out, and the patients will be followed up and examined at 6 months after surgery or at the end of adjuvant treatments and then annually for 10 years (with control mammography).
Patients who have had conservative surgery will have an MRI at 6 months from the end of radiotherapy.
All patients will be asked to complete quality of life questionnaires at baseline, 6 and 12 months post-surgery, and annually for 9 years:
EORTC QLQ-C30 (up to 5 years only), Short Form (36) Health Survey questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with extensive ductal carcinoma in situ with an indication for mastectomy receiving neoadjuvant hormone therapy with Tamoxifen (non-menopausal patients) or Anastrozole (postmenopausal patients)
| Arm | Type | Receives |
|---|---|---|
| Extended ductal carcinoma in situ with mastectomy indication | Experimental | Drug: Tamoxifen 20 mg, Drug: Anastrozole 1Mg TabPatients receive 6 months of tamoxifen or anastrozole in a neoadjuvant situation. Tamoxifen and Anastrozole will be delivered in their original packaging at J0 and M3 : * Tamoxifen: box of tablets dosed at 20 mg * Anastrozole: box of tablets 1 mg. Tamoxifen will be initiated in premenopausal patients orally at a standard dose of 20mg/day as a single dose for 6 months. Anastrozole will be administered orally to postmenopausal patients at the standard dose of 1mg/day in a single dose for 6 months. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient ≥ 40 years old
- Histological diagnosis of ductal carcinoma in situ without infiltrating contingent
- Clinical T0N0
- Estrogen receptor positive (OR+) regardless of progesterone receptor (PR) status
- Indication for mastectomy
Key exclusion criteria (15 listed)
- Invasive breast carcinoma
- Lobular carcinoma in situ
- pN+ patient
- Indication for conservative surgery
- Contraindications to anastrozole or tamoxifen
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 |
|---|---|---|
| Tamoxifen 20 mgTamoxifen will be initiated in non menopausal patients orally for 6 months in a neoadjuvant situation. | Drug | Extended ductal carcinoma in situ with mastectomy indication |
| Anastrozole 1Mg TabAnastrozole will be initiated in menopausal patients orally for 6 months in a neoadjuvant situation. | Drug | Extended ductal carcinoma in situ with mastectomy indication |
Primary outcome
Efficacy of neoadjuvant hormonotherapy
Time frame: 6 months of hormonotherapy
% of conservative surgeries performed after hormonotherapy
6 secondary outcomes
Disease-free survival (DFS)
Time frame: 5 and 10 years post-surgery
Overall survival (OS)
Time frame: 5 and 10 years post-surgery
Pathologic Complete Response (pCR)
Time frame: 6 months of hormonotherapy
Predictive factors of response
Time frame: 3 and 6 months of hormonotherapy
Quality of Life (Qol)
Time frame: At baseline, at 6 months and 12 months post-surgery, and then each year for 4 years
Quality of Life (Qol)
Time frame: At baseline, at 6 months and 12 months post-surgery, and then each year for 9 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 22 Apr 2022.
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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.
Victoire BRILLAUD-MEFLAH, MD principal investigator
Institut de Cancérologie de l'Ouest
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamoxifen 20 mg and Anastrozole 1Mg Tab in people with Ductal Carcinoma in Situ and Extensive Disease, run by Institut Cancerologie de l'Ouest at 8 sites 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 9 inclusion and 15 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 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Victoire BRILLAUD-MEFLAH, MD (0240679818 ext. +33, Victoire.brillaud-meflah@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of neoadjuvant hormonotherapy (time frame: 6 months of hormonotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2022.