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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

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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

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

Inclusion Criteria

The following information on clinical trials is provided for information purposes only to
allow participants and physicians to have an initial discussion about the trial. This
information is not intended to be complete information about the trial, to contain all
considerations that may be relevant to potential participation in the trial, or to replace
the advice of a personal physician or health professional.


1. Histologically or cytologically proven adenocarcinoma of the breast at first

2. Stage IV disease with at least one measurable lesion according to the RECIST criteria

3. HER2/neu positive as determined by 3+ immunohistochemistry (IHC) staining or
fluorescence in situ hybridization (FISH) positivity or negative tumors

4. Life expectancy of >/= 24 weeks

5. No prior chemotherapy for metastatic breast cancer. (Prior endocrine therapy is

6. 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)

7. At least 4 weeks since prior surgery, radiotherapy, endocrine therapy, or
experimental drug therapy with complete recovery from the effects of these

8. 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

9. 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.

10. 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


1. Prior chemotherapy for metastatic breast cancer

2. Prior treatment with bevacizumab or other anti-VEGF therapy

3. 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

4. Current or prior history of brain or leptomeningeal metastases

5. Presence of neuropathy >/= 2

6. Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically
significant (>/= Grade 2) peripheral vascular disease

7. 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

8. Clinically significant cardiovascular disease

9. 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

10. History of bleeding diathesis or coagulopathy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS) Rate: Percentage of Participants With PFS

Outcome Description:

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

Outcome Time Frame:

Up to 6 months and 12 months after treatment initiation

Safety Issue:


Principal Investigator

Barry Childs, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

April 2012

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



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