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Anti-Angiogenesis Treatment After Preoperative Chemotherapy: A Pilot Study in Women With Operable Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Anti-Angiogenesis Treatment After Preoperative Chemotherapy: A Pilot Study in Women With Operable Breast Cancer

This study is broken into 4 groups (A, B, C, and D). Enrollment closed to all groups in May

The first forty subjects (Group A) in this study were treated with Bevacizumab only, which
is given through a vein over 1-2 hours every 3 weeks, for a total of approximately 12 months
(17 cycles). Each cycle consists of 3 weeks.

The next forty subjects (Group B) were treated with Bevacizumab and metronomic CM
chemotherapy. These subjects took cyclophosphamide (1 pill by mouth every day),
methotrexate, (1 pill taken by mouth twice a day for the first two days of each week) and
Bevacizumab (once every 3 weeks). The treatments with cyclophosphamide, methotrexate and
Bevacizumab will continue for approximately 6 months (8 cycles). Then for the next 6 months,
they received Bevacizumab treatments only. The total time on this study will be about 12
months (17 cycles).

The next forty subjects (Group C) were treated with Bevacizumab and Capecitabine
chemotherapy. These subjects took Capecitabine pills twice a day for 14 days, then one week
of rest, to complete a 21-day cycle. There will be a total of 6 cycles of Capecitabine,
meaning 18 weeks of treatment with both Capecitabine and Bevacizumab. Then received
Bevacizumab treatments only (11 cycles) to complete 12 months of therapy. Total duration of
your treatment will be about 12 months or 17 cycles of therapy.

The last forty subjects (Group D) are being treated with Bevacizumab and Capecitabine
chemotherapy on a different schedule. These subjects will take Capecitabine pills twice a
day for 7 days, then one week of rest and repeat this for a total of 24 weeks (6 cycles).
Each cycle will last for 4 weeks (28 days). There will be a total of 6 cycles of
Capecitabine, meaning 24 weeks of treatment with both Capecitabine and Bevacizumab.
Bevacizumab will be given every two weeks for a total of 24 weeks (6 cycles). Then they will
receive Bevacizumab treatments only, every 3 weeks for additional 27 weeks (9 cycles) to
complete 12 months of therapy. For the last 9 cycles of Bevacizumab therapy each cycle will
consist of 3 weeks. Total duration of treatment will be about 12 months or 15 cycles of

Inclusion Criteria:

- Histologically or cytologically confirmed invasive breast cancer, preoperative stages
II-III per AJCC 6th edition, based on baseline evaluation by clinical examination
and/or breast imaging

- Patients must have completed preoperative (neoadjuvant) chemotherapy with a standard
chemotherapy regimen. No more chemotherapy should be planned.

- Patients must have completed definitive resection of primary tumor with adequate
excision of gross disease.

- For patients receiving adjuvant radiation therapy, treatment must be completed prior
to initiation of protocol therapy.

- Patients must have the presence of significant residual invasive disease on
pathologic review following their preoperative chemotherapy.

- LVEF > institutional limits of normal after preoperative chemotherapy, as assessed by
ECHO or nuclear medicine gated study, within 30 days prior to initiating
protocol-based treatment.

- ECOG performance status 0-1

Exclusion Criteria:

- Inadequate organ function, as measured by laboratory assessment after preoperative
chemotherapy and within 14 days of beginning protocol-based treatment

- Patients with metastatic disease are ineligible.

- Known HIV infection

- Patients may not be pregnant, expect to become pregnant, plan to conceive a child
while on study, or breastfeeding

- Uncontrolled intercurrent illness

- Non-healing wounds or major surgical procedures (such as breast surgery) other than
that for venous access device or diagnostic study are not permitted within 28 day
prior to enrollment

- History of abdominal fistula, GI perforation, intra-abdominal abscess, or serious,
non-healing wound, ulcer, or bone fracture within 6 months prior to initiating

- Patients with any history of arterial thromboembolic events, including transient
ischemic attack (TIA), cerebrovascular event (CVA), unstable angina, or myocardial
infarction (MI) within the past 6 months. Patients with clinically significant
peripheral arterial disease should also be excluded

- History of bleeding diathesis or coagulopathy

- History of grade 3 or 4 allergic reactions to compounds of similar chemical or
biologic composition to cyclophosphamide (such as other alkylating agents) or
methotrexate (such as other antimetabolites)

- Prior history of malignancy treated without curative intent, excluding
nonmelanomatous skin cancer

- Patients with large or rapidly accumulating pleural or abdominal effusions

- Current use of anticoagulants is allowed as long as patients have been on a stable
dose for more than two weeks with stable INR

- Chronic therapy with full dose aspirin (< 325 mg/day) or standard non-steroidal
anti-inflammatory agents is allowed

- Patients may not receive other investigational agents while on study

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:

To determine the feasibility of bevacizumab administration with or without concurrent use of metronomic chemotherapy or capecitabine therapy in the adjuvant setting in women with breast cancer previously treated with preoperative chemotherapy.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Harold J Burstein, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

December 2011

Related Keywords:

  • Breast Cancer
  • Bevacizumab
  • Metronomic Chemotherapy
  • Breast Cancer Stages II-III
  • Invasive breast cancer stages II-III
  • Breast Neoplasms



Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
University of California, San Francisco San Francisco, California  94143
University of North Carolina Chapel Hill, North Carolina  27599