Breast CancerPhase 2NCT00364611
Pilot Study of Docetaxel & Bevacizumab +/- Trastuzumab in First-Line Treatment of Patients With Metastatic Breast Cancer
A Phase 2 study testing Bevacizumab, Docetaxel and Trastuzumab in people with Breast Cancer, run by Sanofi at 1 site in United States.
Trial summary
Pilot, phase II, parallel-group, open-label, noncomparative, prospective, multicenter study designed to evaluate the progression-free survival of docetaxel and bevacizumab ± trastuzumab for the first-line treatment of participants with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bevacizumab, Docetaxel and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Apr 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically or cytologically proven adenocarcinoma of the breast at first diagnosis
- Stage IV disease with at least one measurable lesion according to the RECIST criteria
- HER2/neu positive as determined by 3+ immunohistochemistry (IHC) staining or fluorescence in situ hybridization (FISH) positivity or negative tumors
- Life expectancy of >/= 24 weeks
- No prior chemotherapy for metastatic breast cancer. (Prior endocrine therapy is permitted).
- Prior neoadjuvant or adjuvant chemotherapy is permitted, or at least 12 months must have elapsed since the neoadjuvant or adjuvant therapy. Subjects may have received prior adjuvant anthracyclines (maximum cumulative dose, 360 mg/m^2 doxorubicin or 750 mg/m^2 epirubicin)
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- At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or experimental drug therapy with complete recovery from the effects of these interventions
- It is recommended that all baseline staging should be completed within 35 days prior to study entry. All subjects will have the following workup as applicable; CT scan of brain, CT scan or MRI of chest and abdomen, and bone scan or PET scan. In cases of positive bone or PET scans, bone X-ray evaluation and/or MRI is required to confirm or exclude metastatic bone disease. Subjects with metastatic disease limited to bone are ineligible unless at least one lytic lesion is measurable and can be followed by RECIST criteria. Other tests may be performed as clinically indicated
- Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) of >/= 50% or shortening fraction (multiple-gated acquisition [MUGA] scan or echocardiography respectively). The result must be greater than the lower limit of normal (LLN) for the institution.
- Subjects receiving bisphosphonate therapy; however, if bisphosphonates were started within <2 months prior to treatment the bone lesions will not be evaluated for response, and the subjects must have another site of metastatic disease that is either measurable or evaluable for response
Who cannot join
- Prior chemotherapy for metastatic breast cancer
- Prior treatment with bevacizumab or other anti-VEGF therapy
- Concurrent treatment with any other non-protocol anticancer therapy with the exception of radiation therapy as long as all target lesions being followed are not in the radiation field and if HER2/neu positive, HER2/neu-directed therapy
- Current or prior history of brain or leptomeningeal metastases
- Presence of neuropathy >/= 2
- Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (>/= Grade 2) peripheral vascular disease
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- History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma in-situ of the cervix
- Clinically significant cardiovascular disease
- Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning therapy
- History of bleeding diathesis or coagulopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Pilot, Phase II, Multicenter, Open-Label, Prospective Evaluation of Docetaxel and Bevacizumab ± Trastuzumab in the First-Line Treatment of Patients With Metastatic Breast Cancer
Pilot, phase II, parallel-group, open-label, noncomparative, prospective, multicenter study designed to evaluate the progression-free survival of docetaxel and bevacizumab ± trastuzumab for the first-line treatment of participants with metastatic breast cancer. Participants were stratified according to human epidermal growth factor receptor-2 (HER2) status at the time of enrollment. HER2 negative participants were assigned to receive docetaxel and bevacizumab (DB). HER2 positive participants were assigned to receive docetaxel, bevacizumab, and trastuzumab (DBT).
All participants (except one) were off study treatment on 30 June 2011. All efficacy analysis and safety analysis was performed using the cut-off date of June 2011. One participant continued treatment till 11 March 2012. For this participant, adverse events were collected upto 19 April 2012 and included in the safety analysis.
Read the detailed description
The study included:
- Study registration on Day 1: Treatment Cycle 1 was initiated within 14 days of signing informed consent
- Treatment was administered in 3 week treatment cycles until the participant developed unacceptable toxicity, had disease progression, withdrew consent, or died
- If participants experienced a complete response (CR), partial response (PR), or stable disease (SD) at Cycle 8 or beyond or had unacceptable toxicity due to docetaxel, they could continue on bevacizumab and/or trastuzumab until they developed unacceptable toxicity, had disease progression, or withdrew consent
- Participants had follow-up assessments within 30 days after discontinuation of treatment with the last of the study drugs for any reason other than death
- Conditions
- Breast Cancer
- Being tested
- Bevacizumab, Docetaxel, Trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Bevacizumab (Avastin) 15 mg/kg will be administered prior to chemotherapy on
- On Day 1 of the 1st cycle over 120 minutes
- On Day 1 of the 2nd cycle over 90 minutes, if no reaction on the first dose
- On Day 1 of 3rd cycle over 60 minutes, if no reaction on previous doses
- On Day 1 of subsequent cycles over 30 minutes, if no reaction on previous doses
DocetaxelDrug
Docetaxel 75 mg/m^2 IV infused over 60 minutes after completion of Bevacizumab infusion q3w
TrastuzumabDrug
Also called Herceptin
- A loading dose of 8 mg/kg Trastuzumab (Herceptin) IV will be infused over 90 minutes on Day 2 of Cycle 1.
- For all subsequent cycles 6 mg/kg trastuzumab will be administered on Day 1 one hour following completion of docetaxel infusion
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel and Bevacizumab | Experimental | Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met Receives: Drug: Bevacizumab; Drug: Docetaxel |
| Docetaxel, Bevacizumab and Trastuzumab | Experimental | Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met Receives: Drug: Bevacizumab; Drug: Docetaxel; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) Rate: Percentage of Participants With PFS
PFS was the time from registration to first documentation of
- progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors (RECIST) - criteria pre-defining changes in lesion size or appearance
- symptomatic deterioration
- death due to any cause (in absence of PD).
The Percentage of participants with PFS is reported.
For the analysis, participants were censored
- on the last available tumor assessment date on study treatment if they
- had no PFS event
- were on anticancer therapy not related to study treatment
- on the registration date if they
- did not receive study drug
- had no post baseline tumor assessment
Measured: Up to 6 months and 12 months after treatment initiation
Time to Progression-free Survival (PFS)
Time to PFS was the interval from the date of registration to the earliest of the following documented dates:
- PD as defined by RECIST (criteria pre-defining changes in lesion size or appearance)
- symptomatic deterioration
- death.
Time to PFS was estimated from Kaplan-Meier Plots.
Measured: From treatment initiation to PFS event (up to June 2011)
Secondary outcomes (5)
Confirmed Overall Response (OR) Based on RECIST Criteria
Confirmed OR was confirmed Complete Response (CR) + confirmed Partial Response (PR). According to RECIST
- CR was the disappearance of all tumor lesions
- PR was a pre-defined decrease in the size of tumor lesions.
To determine a response, radiologic tumors assessments were performed using computed tomography (CT) and/or magnetic resonance imaging (MRI) of the chest, and the abdomen, bone scan or positron emission tomography (PET) scan, and other imaging techniques as clinically indicated. To confirm a response, 2 assessments separated by 28 days or more were required.
Measured: From treatment initiation to June 2011
Number of Participants With Confirmed Clinical Benefit Based on RECIST Criteria
Clinical Benefit (CB) was achieved in participants with a response (CR + PR) or a stable disease (SD).
According to RECIST
- CR was the disappearance of all tumor lesions
- PR was a pre-defined decrease in the size of tumor lesions
- SD was neither sufficient decrease in tumor size to qualify for PR or sufficient increase to qualify for PD.
Confirmation of a response needed 2 responses scored, separated by 28 days or more (for CR and PR), and by 26 weeks or more (for SD).
Measured: From treatment initiation to June 2011
Duration of Response (DR)
DR was the interval from date of initial documented confirmed response (CR or PR) to the first documented confirmed date of disease progression (PD) or death from any cause in the absence of previous documentation of objective tumor progression.
Participants who were alive and without any record of PD at the time of discontinuation were censored at the last available tumor assessment date; participants with non-study anti-cancer therapy during the study were censored at the last available tumor assessment date prior to the anti-cancer therapy.
DR was estimated from Kaplan-Meier Plots.
Measured: From treatment initiation to June 2011
Overall Survival (OS) Time
OS was the interval between the date of study entry and the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.
OS time was estimated from Kaplan-Meier Plots.
Measured: From treatment initiation to June 2011
Number of Participants With Adverse Events (AE)
An adverse event (AE) was any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the clinical study. AEs occurring on or after first dose of study medication inclusive to 30 days post-last dose were the treatment emergent adverse events (TEAEs).
An serious adverse event was an AE that at any dose (including overdose) resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly, and/or was medically important.
Measured: From treatment initiation to 30 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJun 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barry Childs, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364611
- Sponsor's protocol ID
- DOCET_L_00712
- Status last verified
- Apr 2012
- First submitted
- 14 Aug 2006
- Last updated
- 23 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Phase II, Multicenter, Open-Label, Prospective Evaluation of Docetaxel and Bevacizumab ± Trastuzumab in the First-Line Treatment of Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00364611
- Acronym / sponsor ID
- DOCET_L_00712
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Posted 23 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot, phase II, parallel-group, open-label, noncomparative, prospective, multicenter study designed to evaluate the progression-free survival of docetaxel and bevacizumab ± trastuzumab for the first-line treatment of participants with metastatic breast cancer. Participants were stratified according to human epidermal growth factor receptor-2 (HER2) status at the time of enrollment. HER2 negative participants were assigned to receive docetaxel and bevacizumab (DB). HER2 positive participants were assigned to receive docetaxel, bevacizumab, and trastuzumab (DBT).
All participants (except one) were off study treatment on 30 June 2011. All efficacy analysis and safety analysis was performed using the cut-off date of June 2011. One participant continued treatment till 11 March 2012. For this participant, adverse events were collected upto 19 April 2012 and included in the safety analysis.
Detailed description
The study included:
- Study registration on Day 1: Treatment Cycle 1 was initiated within 14 days of signing informed consent
- Treatment was administered in 3 week treatment cycles until the participant developed unacceptable toxicity, had disease progression, withdrew consent, or died
- If participants experienced a complete response (CR), partial response (PR), or stable disease (SD) at Cycle 8 or beyond or had unacceptable toxicity due to docetaxel, they could continue on bevacizumab and/or trastuzumab until they developed unacceptable toxicity, had disease progression, or withdrew consent
- Participants had follow-up assessments within 30 days after discontinuation of treatment with the last of the study drugs for any reason other than death
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel and Bevacizumab | Experimental | Drug: Bevacizumab, Drug: DocetaxelStratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met |
| Docetaxel, Bevacizumab and Trastuzumab | Experimental | Drug: Bevacizumab, Drug: Docetaxel, Drug: TrastuzumabStratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically proven adenocarcinoma of the breast at first diagnosis
- Stage IV disease with at least one measurable lesion according to the RECIST criteria
- HER2/neu positive as determined by 3+ immunohistochemistry (IHC) staining or fluorescence in situ hybridization (FISH) positivity or negative tumors
- Life expectancy of >/= 24 weeks
- No prior chemotherapy for metastatic breast cancer. (Prior endocrine therapy is permitted).
Key exclusion criteria (10 listed)
- Prior chemotherapy for metastatic breast cancer
- Prior treatment with bevacizumab or other anti-VEGF therapy
- Concurrent treatment with any other non-protocol anticancer therapy with the exception of radiation therapy as long as all target lesions being followed are not in the radiation field and if HER2/neu positive, HER2/neu-directed therapy
- Current or prior history of brain or leptomeningeal metastases
- Presence of neuropathy >/= 2
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 |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab (Avastin) 15 mg/kg will be administered prior to chemotherapy on * On Day 1 of the 1st cycle over 120 minutes * On Day 1 of the 2nd cycle over 90 minutes, if no reaction on the first dose * On Day 1 of 3rd cycle over 60 minutes, if no reaction on previous doses * On Day 1 of subsequent cycles over 30 minutes, if no reaction on previous doses | Drug | Docetaxel and Bevacizumab, Docetaxel, Bevacizumab and Trastuzumab |
| DocetaxelDocetaxel 75 mg/m^2 IV infused over 60 minutes after completion of Bevacizumab infusion q3w | Drug | Docetaxel and Bevacizumab, Docetaxel, Bevacizumab and Trastuzumab |
| TrastuzumabAlso: Herceptin* A loading dose of 8 mg/kg Trastuzumab (Herceptin) IV will be infused over 90 minutes on Day 2 of Cycle 1. * For all subsequent cycles 6 mg/kg trastuzumab will be administered on Day 1 one hour following completion of docetaxel infusion | Drug | Docetaxel, Bevacizumab and Trastuzumab |
Primary outcome
Progression-free Survival (PFS) Rate: Percentage of Participants With PFS
Time frame: Up to 6 months and 12 months after treatment initiation
PFS was the time from registration to first documentation of * progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors (RECIST) - criteria pre-defining changes in lesion size or appearance * symptomatic deterioration * death due to any cause (in absence of PD). The Percentage of participants with PFS is reported. For the analysis, participants were censored * on the last available tumor assessment date on study treatment if they * had no PFS event * were on anticancer therapy not related to study treatment * on the registration date if they * did not receive study drug * had no post baseline tumor assessment
Time to Progression-free Survival (PFS)
Time frame: From treatment initiation to PFS event (up to June 2011)
Time to PFS was the interval from the date of registration to the earliest of the following documented dates: * PD as defined by RECIST (criteria pre-defining changes in lesion size or appearance) * symptomatic deterioration * death. Time to PFS was estimated from Kaplan-Meier Plots.
5 secondary outcomes
Confirmed Overall Response (OR) Based on RECIST Criteria
Time frame: From treatment initiation to June 2011
Number of Participants With Confirmed Clinical Benefit Based on RECIST Criteria
Time frame: From treatment initiation to June 2011
Duration of Response (DR)
Time frame: From treatment initiation to June 2011
Overall Survival (OS) Time
Time frame: From treatment initiation to June 2011
Number of Participants With Adverse Events (AE)
Time frame: From treatment initiation to 30 days after the last dose of study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Barry Childs, MD study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, Docetaxel and Trastuzumab in people with Breast Cancer, run by Sanofi at 1 site in United States.
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 10 inclusion and 10 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: finished, as of the sponsor's last update on 23 Aug 2012. 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 United States. 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?
Yes. Results are posted in the registry (first posted 23 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-free Survival (PFS) Rate: Percentage of Participants With PFS (time frame: Up to 6 months and 12 months after treatment initiation). The study lists 2 primary outcomes in all. 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 23 Aug 2012; AzTrials last refreshed its copy on 8 Nov 2026.