Triple Negative Metastatic Breast CancerPhase 2NCT01069796
Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer
A Phase 2 study testing Paclitaxel, Bevacizumab and Capecitabine in people with Triple Negative Metastatic Breast Cancer, run by ARCAGY/ GINECO GROUP at 17 sites in France.
Trial summary
Patients with triple negative metastatic breast cancer (HER2-, PR-, ER-) will receive bevacizumab, paclitaxel and capecitabine as a first line of treatment (possibility to have received adjuvant chemotherapy). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Metastatic Breast Cancer
- What is being tested?
- Paclitaxel, Bevacizumab and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 17 sitesFrance
- Study dates
- Apr 2010to Jun 2014
- Phase
- Phase 2
- 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
- Female histologically confirmed adenocarcinoma of the breast ER-, PR-, HER2- disease
- Measurable disease
- Patients may received prior radiotherapy as adjuvant treatment or/and metastatic disease provided that they have progressive disease at study entry
Who cannot join
- Prior chemotherapy for metastatic disease
- HER2 positive and/or hormonal receptor positive
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Centre Paul Papin
Angers
Clinique Tivoli
Bordeaux
Centre Hospitalier William Morey
Chalon-sur-Saône
Centre Hospitalier Intercommunal
Fréjus
Clinique des 4 Pavillons
Lormont
Hôpital Privé Clairval
Marseille
Centre Azuréen de Cancérologie
Mougins
Centre Alexis Vautrin
Nancy
Centre Antoine Lacassagne
Nice
Centre Hospitalier Régional
Orléans
Institut Jean Godinot
Reims
Hôpitaux Drôme Nord - Site de Romans-sur-Isère
Romans-sur-Isère
Centre Henri Becquerel
Rouen
Clinique Armoricaine de Radiologie
Saint-Brieuc
Clinique de l'Union
St.-Jean
Centre Paul Strauss
Strasbourg
Centre Hospitalier Bretagne Atlantique
Vannes
About this study
Official title: A Multi Phase II Clinical Trials Evaluating the Association of Bevacizumab With Weekly Paclitaxel and Capecitabine in First Line Treatment for Patients With Triple Negative Metastatic or Locally Advanced Cancer
Patients with triple negative metastatic breast cancer (HER2-, PR-, ER-) will receive bevacizumab, paclitaxel and capecitabine as a first line of treatment (possibility to have received adjuvant chemotherapy).
- Conditions
- Triple Negative Metastatic Breast Cancer
- Being tested
- Paclitaxel, Bevacizumab, Capecitabine
- Keywords
- triple negative, metastatic, breast cancer, First line chemotherapy
- Medical subject headings
- Neoplasm Metastasis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
80 mg/m² weekly
BevacizumabDrug
10 mg/kg d1 d15
CapecitabineDrug
800 mg/m² p.o. twice a day, D1 to D5 week 1, 2 \& 3
| Study group | Role | What they receive |
|---|---|---|
| Association bevacizumab paclitaxel capecitabine breast cancer | Experimental | * bevacizumab 10 mg/kg in IV, D1 and D15
* paclitaxel 80mg/m2 in IV, D1 to D8 and D15
* capecitabine 1600mg/m2/D, per os, D1 to D5, Weeks 1,2 and 3 Receives: Drug: Paclitaxel; Drug: Bevacizumab; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
Measured: 36 months for recrutment and 30 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 posted17 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2012
- Study completionJun 2014
Why it stopped: The number of inclusion was reached normally
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069796
- Sponsor's protocol ID
- A-Taxel (GINECO BR108)
- Status last verified
- Mar 2016
- First submitted
- 16 Feb 2010
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Phase II Clinical Trials Evaluating the Association of Bevacizumab With Weekly Paclitaxel and Capecitabine in First Line Treatment for Patients With Triple Negative Metastatic or Locally Advanced Cancer
- ClinicalTrials.gov ID
- NCT01069796
- Acronym / sponsor ID
- A-Taxel (GINECO BR108)
- Conditions
- Triple Negative Metastatic Breast Cancer
- Keywords
- triple negative, metastatic, breast cancer, First line chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The number of inclusion was reached normally
- Enrolment
- 64 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Feb 2010 (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.
Patients with triple negative metastatic breast cancer (HER2-, PR-, ER-) will receive bevacizumab, paclitaxel and capecitabine as a first line of treatment (possibility to have received adjuvant chemotherapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Association bevacizumab paclitaxel capecitabine breast cancer | Experimental | Drug: Paclitaxel, Drug: Bevacizumab, Drug: Capecitabine* bevacizumab 10 mg/kg in IV, D1 and D15 * paclitaxel 80mg/m2 in IV, D1 to D8 and D15 * capecitabine 1600mg/m2/D, per os, D1 to D5, Weeks 1,2 and 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female histologically confirmed adenocarcinoma of the breast ER-, PR-, HER2- disease
- Measurable disease
- Patients may received prior radiotherapy as adjuvant treatment or/and metastatic disease provided that they have progressive disease at study entry
Key exclusion criteria (2 listed)
- Prior chemotherapy for metastatic disease
- HER2 positive and/or hormonal receptor positive
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 |
|---|---|---|
| Paclitaxel80 mg/m² weekly | Drug | Association bevacizumab paclitaxel capecitabine breast cancer |
| Bevacizumab10 mg/kg d1 d15 | Drug | Association bevacizumab paclitaxel capecitabine breast cancer |
| Capecitabine800 mg/m² p.o. twice a day, D1 to D5 week 1, 2 \& 3 | Drug | Association bevacizumab paclitaxel capecitabine breast cancer |
Primary outcome
objective response rate
Time frame: 36 months for recrutment and 30 months for follow up
Results and safety
The study was stopped early (reason given: The number of inclusion was reached normally). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 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 Paclitaxel, Bevacizumab and Capecitabine in people with Triple Negative Metastatic Breast Cancer, run by ARCAGY/ GINECO GROUP at 17 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 3 inclusion and 2 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 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
The study was stopped early (reason given: The number of inclusion was reached normally). 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?
objective response rate (time frame: 36 months for recrutment and 30 months for follow up). 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 17 Mar 2016.