First Line Metastatic Breast CancerPhase 3NCT01303679
1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer
A Phase 3 study testing Paclitaxel, Bevacizumab and Exemestane in people with First Line Metastatic Breast Cancer, run by ARCAGY/ GINECO GROUP at 1 site in France.
Trial summary
In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- First Line Metastatic Breast Cancer
- What is being tested?
- Paclitaxel, Bevacizumab and Exemestane
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to May 2018
- Phase
- Phase 3
- 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
Who may be able to join
- Age > 18 ans.
- Metastatic breast cancer or locally advanced
- RE+, HER2-
- Patient receiving paclitaxel-bevacizumab first line chemotherapy
Who cannot join
- Previous treatment by exemestane (both in adjuvant or metastatic treatment).
- 1st line of chemotherapy different thaan paclitaxel-bevacizumab.
- Treatment by paclitaxel-bevacizumab > 18 weeks.
- HER2 positifs et/ou récepteurs aux oestrogènes négatifs.
- Previous thrombosis event within the 6 months before inclusion .
- Previous significant surgery within the 28 days before treatment start
- Previuous coagulopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Randomized Multicenter Trial Comparing Continued Maintenance Therapy With the Bevacizumab + Taxane Versus Bevacizumab + Substituting Exemestane in Patients With Metastatic Breast Cancer or Locally Advanced With Estrogen Receptor Positive and Having at Least a Stable Disease After 16 to 18 Weeks of Treatment With Bevacizumab + Taxane.
In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free survival. The investigators make the hypothesis that there would be interest to discontinue treatment with taxane after 4 months, and to begin hormone therapy while continuing maintenance bevacizumab.
Exemestane was chosen because it has been shown potentially active in patients who progressed after letrozole, anastrozole or tamoxifen.
- Conditions
- First Line Metastatic Breast Cancer
- Being tested
- Paclitaxel, Bevacizumab, Exemestane
- Keywords
- First line metastatic breast cancer, Positive estrogen receptors, Negative HER2 receptors, At least stable disease after 4 months of paclitaxel-bevcizumab induction chemotheray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
IV, 80mg/m² at d1, d8, d15
BevacizumabDrug
IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks
ExemestaneDrug
daily 25 mg (1 pill) oral intake
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel-bevacizumab | Active comparator | Paclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15 Receives: Drug: Paclitaxel; Drug: Bevacizumab |
| exemestane-bevacizumab | Experimental | exemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks Receives: Drug: Bevacizumab; Drug: Exemestane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary free survival
Measured: 24 months for recruitment and 18 months for follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2014
- Study completionMay 2018
Why it stopped: Not reveal any significant difference between the 2 treatment arms
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for First Line 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas BACHELOT, Md, Principal investigator, GINECO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303679
- Sponsor's protocol ID
- Arobase (GINECO-BR107)
- Status last verified
- Sep 2023
- First submitted
- 23 Feb 2011
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tredan O, Follana P, Moullet I, Cropet C, Trager-Maury S, Dauba J, Lavau-Denes S, Dieras V, Beal-Ardisson D, Gouttebel M, Orfeuvre H, Stefani L, Jouannaud C, Burki F, Petit T, Guardiola E, Becuwe C, Blot E, Pujade-Lauraine E, Bachelot T. A phase III trial of exemestane plus bevacizumab maintenance therapy in patients with metastatic breast cancer after first-line taxane and bevacizumab: a GINECO group study. Ann Oncol. 2016 Jun;27(6):1020-1029. doi: 10.1093/annonc/mdw077. Epub 2016 Feb 24.
PubMed 26916095
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Multicenter Trial Comparing Continued Maintenance Therapy With the Bevacizumab + Taxane Versus Bevacizumab + Substituting Exemestane in Patients With Metastatic Breast Cancer or Locally Advanced With Estrogen Receptor Positive and Having at Least a Stable Disease After 16 to 18 Weeks of Treatment With Bevacizumab + Taxane.
- ClinicalTrials.gov ID
- NCT01303679
- Acronym / sponsor ID
- Arobase (GINECO-BR107)
- Conditions
- First Line Metastatic Breast Cancer
- Keywords
- First line metastatic breast cancer, Positive estrogen receptors, Negative HER2 receptors, At least stable disease after 4 months of paclitaxel-bevcizumab induction chemotheray
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not reveal any significant difference between the 2 treatment arms
- Enrolment
- 117 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 25 Feb 2011 (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.
In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free survival. The investigators make the hypothesis that there would be interest to discontinue treatment with taxane after 4 months, and to begin hormone therapy while continuing maintenance bevacizumab.
Exemestane was chosen because it has been shown potentially active in patients who progressed after letrozole, anastrozole or tamoxifen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paclitaxel-bevacizumab | Active comparator | Drug: Paclitaxel, Drug: BevacizumabPaclitaxel, 80mg/m² at d1, d8, d15 bevacizumab, 10 mg/kg at d1, d15 |
| exemestane-bevacizumab | Experimental | Drug: Bevacizumab, Drug: Exemestaneexemestane, 25 mg daily dose bevacizumab, 15mg/kg every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 ans.
- Metastatic breast cancer or locally advanced
- RE+, HER2-
- Patient receiving paclitaxel-bevacizumab first line chemotherapy
Key exclusion criteria (7 listed)
- Previous treatment by exemestane (both in adjuvant or metastatic treatment).
- 1st line of chemotherapy different thaan paclitaxel-bevacizumab.
- Treatment by paclitaxel-bevacizumab > 18 weeks.
- HER2 positifs et/ou récepteurs aux oestrogènes négatifs.
- Previous thrombosis event within the 6 months before inclusion .
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 |
|---|---|---|
| PaclitaxelIV, 80mg/m² at d1, d8, d15 | Drug | paclitaxel-bevacizumab |
| BevacizumabIV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks | Drug | exemestane-bevacizumab, paclitaxel-bevacizumab |
| Exemestanedaily 25 mg (1 pill) oral intake | Drug | exemestane-bevacizumab |
Primary outcome
Primary free survival
Time frame: 24 months for recruitment and 18 months for follow up
Results and safety
The study was stopped early (reason given: Not reveal any significant difference between the 2 treatment arms). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Derived from this study: PubMed 26916095Tredan O, Follana P, Moullet I, Cropet C, Trager-Maury S, Dauba J, Lavau-Denes S, Dieras V, Beal-Ardisson D, Gouttebel M, Orfeuvre H, Stefani L, Jouannaud C, Burki F, Petit T, Guardiola E, Becuwe C, Blot E, Pujade-Lauraine E, Bachelot T. A phase III trial of exemestane plus bevacizumab maintenance therapy in patients with metastatic breast cancer after first-line taxane and bevacizumab: a GINECO group study. Ann Oncol. 2016 Jun;27(6):1020-1029. doi: 10.1093/annonc/mdw077. Epub 2016 Feb 24.
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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.
Thomas BACHELOT, Md principal investigator
GINECO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paclitaxel, Bevacizumab and Exemestane in people with First Line Metastatic Breast Cancer, run by ARCAGY/ GINECO GROUP 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 6 Sep 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Not reveal any significant difference between the 2 treatment arms). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary free survival (time frame: 24 months for recruitment and 18 months for follow up). 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 NCT01303679, which also lists 1 linked publication.
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 6 Sep 2023.