Breast CancerPhase 2NCT00365365
Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab With or Without Trastuzumab for Adjuvant Treatment of Patients With Breast Cancer
A Phase 2 study testing Doxorubicin and cyclophosphamide (AC) + bevacizumab, Docetaxel (T) + bevacizumab and Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab in people with Breast Cancer, run by Sanofi at 1 site in United States.
Trial summary
This is a phase IIb, randomized, parallel-group, noncomparative, multicenter, pilot study designed to evaluate the safety and efficacy of bevacizumab with or without (+/-) trastuzumab administered with three different docetaxel-based combination regimens for the adjuvant treatment of participants with node positive or… 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?
- Doxorubicin and cyclophosphamide (AC) + bevacizumab, Docetaxel (T) + bevacizumab and Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Oct 2011
- 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
- Women >/= 18 years of age.
- Histologically proven breast cancer with an interval between definitive breast surgery that includes axillary lymph node (LN) dissection or axillary nodal evaluation and study registration of < 60 days. (Note: Cycle 1 of chemotherapy treatment may NOT be infused until > 28 days after the date of definitive breast surgery and the participant must be recovered from any clinically significant toxicity thereof.)
- Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection (axillary lymph node evaluation can be either full axillary node dissection or sentinel LN evaluation followed by dissection if sentinel LN is positive) for operable breast cancer (pT1-4 [including inflammatory], pNO-3, and MO). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.
- Subjects must be either lymph node-positive (pN1-3) or lymph node-negative (pN0) with high-risk features as determined by Investigator.
- High-risk, lymph node-negative participants, (pN0) will be defined as subjects having invasive adenocarcinoma with either a negative sentinel node biopsy (pN0[sn]) OR negative lymph node dissection (pN0) disease AND tumor size > 2 cm or tumor size >/= 1 cm with at least one of the following factors:
- negative estrogen receptor (ER) and negative progesterone receptor (PR) status
Show all 19Show fewer
- histologic and/or nuclear Grade 2-3; or
- age < 35 years
- HER2/neu positive or negative tumors are eligible. HER2 positivity must be documented by fluorescence in situ hybridization (FISH).
- Estrogen and progesterone receptor status must be performed on the primary tumor prior to study entry. Results must be pending or known at the time of study entry.
- Normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF) 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.
- Hematology evaluation within 2 weeks prior to study entry:
- Absolute neutrophil count (ANC) >/= 1,500/μL
- Platelets >/= 100,000/μL
- Hemoglobin >/= 9 g/dL
- Hepatic function evaluation within 2 weeks prior to study entry:
- Total bilirubin </= ULN for the institution
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be in the acceptable range.
- Complete staging work-up as follows: All subjects must have an appropriate radiographic evaluation, e.g., computed tomography (CT), positron emission tomography (PET)/CT, and/or (magnetic resonance imaging) MRI of the brain, chest, abdomen and pelvis, and imaging of bone by either a bone scan or PET scan. In cases of positive bone imaging, a bone X-ray or MRI evaluation is mandatory to rule out the possibility of metastatic bone scan disease. Other tests may be performed as clinically indicated. It is recommended that all baseline staging should be completed within 35 days prior to study entry.
Who cannot join
- Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
- Prior anthracycline therapy, taxoids or platinum salts for any malignancy.
- Prior radiation therapy for breast cancer or any radiotherapy to the chest wall for any other malignancy.
- Bilateral invasive breast cancer.
- Pregnant or lactating subjects
- Cardiac disease or risk for same as judged by Investigator
Show all 13Show fewer
- Other serious illness or medical conditions such as (partial list- review with Investigator) history of significant neurologic or psychiatric disorders that would prohibit the understanding and giving of informed consent, active uncontrolled infection, active peptic ulcer, unstable diabetes mellitus or subjects with symptomatic, intrinsic lung disease resulting in dyspnea at rest
- Current therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention of breast cancer. Subjects must have discontinued these agents prior to study entry.
- Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment must be stopped prior to study entry.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational non-marketed drug within 30 days prior to study entry.
- Concurrent treatment with any other anti-cancer therapy.
- Male subjects, as no clinical efficacy or safety data are available from phase I-II studies.
- Chemotherapy and/or bevacizumab may not be given until > 7 days following a minor surgical procedure. Chemotherapy may be given without bevacizumab in circumstances in which the participant has recovered sufficiently to receive chemotherapy but has not yet reached a 28 day time point at which bevacizumab could be administered.
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 Phase IIb, Randomized, Multicenter, Noncomparative Pilot Study of the Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab ± Trastuzumab for the Adjuvant Treatment of Patients With Node-Positive & High-Risk Node-Negative Breast Cancer
This is a phase IIb, randomized, parallel-group, noncomparative, multicenter, pilot study designed to evaluate the safety and efficacy of bevacizumab with or without (+/-) trastuzumab administered with three different docetaxel-based combination regimens for the adjuvant treatment of participants with node positive or high-risk node negative breast cancer.
Read the detailed description
In this study, participants were stratified according to HER2 status at the time of enrollment. HER2-negative participants were randomized in a 1:1 ratio to either stratum 1 (AC->T sequential + bevacizumab) or stratum 2 (TAC + bevacizumab). All HER2-positive participants were assigned to stratum 3 (TCH + bevacizumab).
The study included a treatment period of 1 year, followed by a 2 year posttreatment survival follow-up period.
- Conditions
- Breast Cancer
- Being tested
- Doxorubicin and cyclophosphamide (AC) + bevacizumab, Docetaxel (T) + bevacizumab, Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab, Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab, Bevacizumab and trastuzumab maintenance therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxorubicin and cyclophosphamide (AC) + bevacizumabDrug
Also called Avastin® (bevacizumab), Adriamycin® (doxorubicin)
For every 3-week cycle
- bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by
- doxorubicin 60 mg/m^2 IV push or infusion followed by cyclophosphamide 600 mg/m^2 IV push or infusion
- Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy
Docetaxel (T) + bevacizumabDrug
Also called Taxotere® (docetaxel), Avastin® (bevacizumab)
For every 3-week cycle
- bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by
- docetaxel 100 mg/m^2 IV
- Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy
Note: The starting dose of docetaxel was reduced to 75 mg/m^2 if toxicity occurred that met the criteria for doxorubicin dose reduction
Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumabDrug
Also called Taxotere® (docetaxel), Avastin® (bevacizumab)
For every 3-week cycle
- bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by
- doxorubicin 50 mg/m^2 IV push or infusion followed by cyclophosphamide 500 mg/m^2 IV push or infusion followed by docetaxel 75 mg/m^2
- Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy
Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumabDrug
Also called Taxotere® (docetaxel), Herceptin® (trastuzumab), Avastin® (bevacizumab)
For every 3-week cycle
- bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by
- docetaxel in 75 mg/m^2 IV followed by carboplatin AUC 6 mg/mL/min IV followed by
- trastuzumab 6 mg/kg by IV infusion (For the first cycle 1 only a loading dose of trastuzumab 8 mg/kg IV was infused on Day 2)
- Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy
Bevacizumab and trastuzumab maintenance therapyDrug
Also called Avastin® (bevacizumab), Herceptin® (trastuzumab)
- bevacizumab 15 mg/kg was infused IV followed by
- trastuzumab 6 mg/kg IV
Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed.
Bevacizumab maintenance therapyDrug
Also called Avastin® (bevacizumab)
- bevacizumab 15 mg/kg was infused IV
Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed.
| Study group | Role | What they receive |
|---|---|---|
| Stratum 1 (AC->T + bevacizumab) | Experimental | HER2-negative participants administered
* doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by
* docetaxel (T) + bevacizumab for 4 cycles followed by
* bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed Receives: Drug: Doxorubicin and cyclophosphamide (AC) + bevacizumab; Drug: Docetaxel (T) + bevacizumab; Drug: Bevacizumab maintenance therapy |
| Stratum 2 (TAC + bevacizumab) | Experimental | HER2-negative participants administered
* docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by
* bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed Receives: Drug: Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab; Drug: Bevacizumab maintenance therapy |
| Stratum 3 (TCH + bevacizumab) | Experimental | All HER2-positive participants administered
* docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by
* bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed Receives: Drug: Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab; Drug: Bevacizumab and trastuzumab maintenance therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Safety - Number of Participants With Grade 3-4 Clinical Congestive Heart Failure (CHF)
Participants were evaluated for clinical CHF every 3 weeks during chemotherapy, every 3 months while on maintenance therapy, and every 3 months during the 2-year follow-up period. Left ventricular ejection fraction (LVEF) of CHF was assessed by multi-gated acquisition (MUGA) or echocardiogram (ECHO) performed midway through completion of chemotherapy according to a treatment-specific schedule, every 12 weeks during maintenance therapy, and at 6 and 24 months after completion of maintenance therapy.
Grade 3-4 CHF were identified through a clinical review of all study collected investigator verbatim and the Medical Dictionary for Regulatory Activities (MedDRA). The preferred terms (PT) cardiac failure congestive, cardiomyopathy, and ejection fraction decreased were associated with CHF.
Measured: from the first dose of study medication up to the end of follow-up (up to 3 yrs)
Secondary outcomes (2)
Safety - Number of Participants With Adverse Events (AE)
An adverse event was any untoward medical occurrence in a participant of the clinical investigation, regardless of the relationship to study treatment.
A serious adverse event (SAE) was an AE that at any dose (including overdose) resulted in death, was life-threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect, and/or was medically important.
Treatment-emergent adverse events (TEAE) were defined as AEs that developed or worsened in severity during the on-treatment period.
Measured: from the administration of the first dose of study medication up to 30 days after the last dose of study medication; events ongoing at the time of discontinuation were monitored in the follow-up period until resolution.
Disease-free Survival (DFS) Rate
DFS was defined as the time from the administration of the first-dose of study medication until recurrence of tumor or death from any cause in the absence of previous documentation of tumor recurrence. DFS rate was the probability of being disease free and alive at a particular time. DFS rates were estimated using Kaplan-Meier Method, and 95% confidence intervals were computed using the method of Kalbfleisch and Prentice.
For participants who did have objective recurrence of tumor and who were still on study at the time of an analysis, or who were given antitumor treatment other than the study treatment, or who were removed from study follow-up prior to documentation of the tumor recurrence, DFS was censored at the last date the participant was known to be disease-free.
Measured: from the administration of the first-dose of study medication up to 12 months, 18 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionOct 2011
- Study completionOct 2011
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vicki Erickson, MSN, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365365
- Sponsor's protocol ID
- DOCET_L_00714
- Status last verified
- Jan 2012
- First submitted
- 16 Aug 2006
- Last updated
- 14 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Randomized, Multicenter, Noncomparative Pilot Study of the Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab ± Trastuzumab for the Adjuvant Treatment of Patients With Node-Positive & High-Risk Node-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT00365365
- Acronym / sponsor ID
- DOCET_L_00714
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 17 Aug 2006 (estimated)
- Results
- Posted 14 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase IIb, randomized, parallel-group, noncomparative, multicenter, pilot study designed to evaluate the safety and efficacy of bevacizumab with or without (+/-) trastuzumab administered with three different docetaxel-based combination regimens for the adjuvant treatment of participants with node positive or high-risk node negative breast cancer.
Detailed description
In this study, participants were stratified according to HER2 status at the time of enrollment. HER2-negative participants were randomized in a 1:1 ratio to either stratum 1 (AC->T sequential + bevacizumab) or stratum 2 (TAC + bevacizumab). All HER2-positive participants were assigned to stratum 3 (TCH + bevacizumab).
The study included a treatment period of 1 year, followed by a 2 year posttreatment survival follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stratum 1 (AC->T + bevacizumab) | Experimental | Drug: Doxorubicin and cyclophosphamide (AC) + bevacizumab, Drug: Docetaxel (T) + bevacizumab, Drug: Bevacizumab maintenance therapyHER2-negative participants administered * doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by * docetaxel (T) + bevacizumab for 4 cycles followed by * bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed |
| Stratum 2 (TAC + bevacizumab) | Experimental | Drug: Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab, Drug: Bevacizumab maintenance therapyHER2-negative participants administered * docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by * bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed |
| Stratum 3 (TCH + bevacizumab) | Experimental | Drug: Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab, Drug: Bevacizumab and trastuzumab maintenance therapyAll HER2-positive participants administered * docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by * bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Women >/= 18 years of age.
- Histologically proven breast cancer with an interval between definitive breast surgery that includes axillary lymph node (LN) dissection or axillary nodal evaluation and study registration of < 60 days. (Note: Cycle 1 of chemotherapy treatment may NOT be infused until > 28 days after the date of definitive breast surgery and the participant must be recovered from any clinically significant toxicity thereof.)
- Definitive surgical treatment must be either mastectomy, or breast conserving surgery with axillary lymph node dissection (axillary lymph node evaluation can be either full axillary node dissection or sentinel LN evaluation followed by dissection if sentinel LN is positive) for operable breast cancer (pT1-4 [including inflammatory], pNO-3, and MO). Margins of resected specimen from definitive surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ does not count as a positive margin.
- Subjects must be either lymph node-positive (pN1-3) or lymph node-negative (pN0) with high-risk features as determined by Investigator.
- High-risk, lymph node-negative participants, (pN0) will be defined as subjects having invasive adenocarcinoma with either a negative sentinel node biopsy (pN0[sn]) OR negative lymph node dissection (pN0) disease AND tumor size > 2 cm or tumor size >/= 1 cm with at least one of the following factors:
Key exclusion criteria (13 listed)
- Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
- Prior anthracycline therapy, taxoids or platinum salts for any malignancy.
- Prior radiation therapy for breast cancer or any radiotherapy to the chest wall for any other malignancy.
- Bilateral invasive breast cancer.
- Pregnant or lactating subjects
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 |
|---|---|---|
| Doxorubicin and cyclophosphamide (AC) + bevacizumabAlso: Avastin® (bevacizumab), Adriamycin® (doxorubicin)For every 3-week cycle * bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by * doxorubicin 60 mg/m^2 IV push or infusion followed by cyclophosphamide 600 mg/m^2 IV push or infusion * Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy | Drug | Stratum 1 (AC->T + bevacizumab) |
| Docetaxel (T) + bevacizumabAlso: Taxotere® (docetaxel), Avastin® (bevacizumab)For every 3-week cycle * bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by * docetaxel 100 mg/m^2 IV * Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy Note: The starting dose of docetaxel was reduced to 75 mg/m^2 if toxicity occurred that met the criteria for doxorubicin dose reduction | Drug | Stratum 1 (AC->T + bevacizumab) |
| Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumabAlso: Taxotere® (docetaxel), Avastin® (bevacizumab)For every 3-week cycle * bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by * doxorubicin 50 mg/m^2 IV push or infusion followed by cyclophosphamide 500 mg/m^2 IV push or infusion followed by docetaxel 75 mg/m^2 * Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy | Drug | Stratum 2 (TAC + bevacizumab) |
| Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumabAlso: Taxotere® (docetaxel), Herceptin® (trastuzumab), Avastin® (bevacizumab)For every 3-week cycle * bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by * docetaxel in 75 mg/m^2 IV followed by carboplatin AUC 6 mg/mL/min IV followed by * trastuzumab 6 mg/kg by IV infusion (For the first cycle 1 only a loading dose of trastuzumab 8 mg/kg IV was infused on Day 2) * Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy | Drug | Stratum 3 (TCH + bevacizumab) |
| Bevacizumab and trastuzumab maintenance therapyAlso: Avastin® (bevacizumab), Herceptin® (trastuzumab)* bevacizumab 15 mg/kg was infused IV followed by * trastuzumab 6 mg/kg IV Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed. | Drug | Stratum 3 (TCH + bevacizumab) |
| Bevacizumab maintenance therapyAlso: Avastin® (bevacizumab)- bevacizumab 15 mg/kg was infused IV Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed. | Drug | Stratum 1 (AC->T + bevacizumab), Stratum 2 (TAC + bevacizumab) |
Primary outcome
Cardiac Safety - Number of Participants With Grade 3-4 Clinical Congestive Heart Failure (CHF)
Time frame: from the first dose of study medication up to the end of follow-up (up to 3 yrs)
Participants were evaluated for clinical CHF every 3 weeks during chemotherapy, every 3 months while on maintenance therapy, and every 3 months during the 2-year follow-up period. Left ventricular ejection fraction (LVEF) of CHF was assessed by multi-gated acquisition (MUGA) or echocardiogram (ECHO) performed midway through completion of chemotherapy according to a treatment-specific schedule, every 12 weeks during maintenance therapy, and at 6 and 24 months after completion of maintenance therapy. Grade 3-4 CHF were identified through a clinical review of all study collected investigator verbatim and the Medical Dictionary for Regulatory Activities (MedDRA). The preferred terms (PT) cardiac failure congestive, cardiomyopathy, and ejection fraction decreased were associated with CHF.
2 secondary outcomes
Safety - Number of Participants With Adverse Events (AE)
Time frame: from the administration of the first dose of study medication up to 30 days after the last dose of study medication; events ongoing at the time of discontinuation were monitored in the follow-up period until resolution.
Disease-free Survival (DFS) Rate
Time frame: from the administration of the first-dose of study medication up to 12 months, 18 months and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 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.
Vicki Erickson, MSN 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 Doxorubicin and cyclophosphamide (AC) + bevacizumab, Docetaxel (T) + bevacizumab and Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab 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 19 inclusion and 13 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 14 Sep 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 14 Sep 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?
Cardiac Safety - Number of Participants With Grade 3-4 Clinical Congestive Heart Failure (CHF) (time frame: from the first dose of study medication up to the end of follow-up (up to 3 yrs)). 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 14 Sep 2012.