Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab With or Without Trastuzumab for Adjuvant Treatment of Patients With Breast Cancer

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• Breast Neoplasms 12,544

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 214 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Study arms

• Experimental
  Stratum 1 (AC->T + bevacizumab)

  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

  Drug: Doxorubicin and cyclophosphamide (AC) + bevacizumab · Drug: Docetaxel (T) + bevacizumab · Drug: Bevacizumab maintenance therapy

• Experimental
  Stratum 2 (TAC + bevacizumab)

  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

  Drug: Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab · Drug: Bevacizumab maintenance therapy

• Experimental
  Stratum 3 (TCH + bevacizumab)

  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

  Drug: Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab · Drug: Bevacizumab and trastuzumab maintenance therapy

Interventions

• DrugDoxorubicin and cyclophosphamide (AC) + bevacizumab

  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

  Also known as: Avastin® (bevacizumab), Adriamycin® (doxorubicin)

• DrugDocetaxel (T) + 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

  Also known as: Taxotere® (docetaxel), Avastin® (bevacizumab)

• DrugDocetaxel, doxorubicin, cyclophosphamide (TAC) + 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

  Also known as: Taxotere® (docetaxel), Avastin® (bevacizumab)

• DrugDocetaxel, carboplatin, trastuzumab (TCH) + 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

  Also known as: Taxotere® (docetaxel), Herceptin® (trastuzumab), Avastin® (bevacizumab)

• DrugBevacizumab and trastuzumab maintenance therapy

  * 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.

  Also known as: Avastin® (bevacizumab), Herceptin® (trastuzumab)

• DrugBevacizumab maintenance therapy

  - 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.

  Also known as: Avastin® (bevacizumab)

Primary outcomes

1. 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.

   Time frame: from the first dose of study medication up to the end of follow-up (up to 3 yrs)

Secondary outcomes

1. 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.

   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.

2. 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.

   Time frame: from the administration of the first-dose of study medication up to 12 months, 18 months and 24 months

Baseline characteristics