Pilot Study of Docetaxel & Bevacizumab +/- Trastuzumab in First-Line Treatment of Patients With Metastatic Breast Cancer

실험적: Docetaxel and Bevacizumab

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

의약품: Bevacizumab

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

다른 이름들:

• 아바스틴

의약품: Docetaxel

Docetaxel 75 mg/m^2 IV infused over 60 minutes after completion of Bevacizumab infusion q3w

실험적: Docetaxel, Bevacizumab and Trastuzumab

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

의약품: Bevacizumab

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

다른 이름들:

• 아바스틴

의약품: Docetaxel

Docetaxel 75 mg/m^2 IV infused over 60 minutes after completion of Bevacizumab infusion q3w

의약품: Trastuzumab

• 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

다른 이름들:

• 허셉틴

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

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.

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.

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).

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.

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.

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.