A Phase II Trial of Preoperative Cisplatin and Bevacizumab in ER-, PR-, Her-2 Negative Breast Cancer
18 Years
N/A
Both
Breast Cancer
Trial Information
A Phase II Trial of Preoperative Cisplatin and Bevacizumab in ER-, PR-, Her-2 Negative Breast Cancer
- To prepare for surgery, a small "clip" will be placed into the tumor area so that the
surgeon can locate the site of the tumor at the time of surgery. This is a standard
procedure for breast cancer.
- The study drugs will be given in four 3-week cycles (about 3 months). Participants
will come into the clinic each day they receive study treatment intravenously.
Cisplatin will be given on day one of the treatment cycle (once every 3 weeks) for four
cycles. Bevacizumab will be given on day one of the treatment cycle for three cycles.
- On day one of each 3-week cycle a physical exam, routine blood tests and urine test
will be performed. 7-8 days after chemotherapy, blood tests and a hearing test will be
performed. A preoperative study visit will take place 7-10 days before surgery and a
physical exam, routine blood tests, EKG and an MRI of the breast will be performed.
- Surgery to remove the tumor will occur at least three weeks after the last dose of
cisplatin and is considered standard of care.
- Postoperative chemotherapy will begin at least three weeks after surgery. Everyone on
the research study will receive four 2-week cycles of doxorubicin and cyclophosphamide
plus bevacizumab. After the 8 weeks, the doctor will decide which of the following two
treatment regimens the participant will receive: Bevacizumab for four 2-week cycles
(once every two weeks) or; Paclitaxel plus bevacizumab for four 2-week cycles (once
every two weeks).
- At the end of the postoperative chemotherapy, the participant will return to the clinic
for a medical history, physical exam, vital signs, performance status, routine blood
tests, MUGA or Echo Scans, and a hearing test.
Inclusion Criteria:
- All tumors must be ER-, PR- and HER2-negative
- Clinical stage T2 or T3, NO-3, MO. Subjects with inflammatory breast cancer are not
eligible
- For subjects with clinically negative axilla, a sentinel lymph node biopsy will be
performed either up front or after preoperative therapy at the discretion of the
subject's physicians; for subjects with a clinically positive axilla, a needle
aspiration or core biopsy will be performed to confirm the presence of metastatic
disease in the lymph nodes.
- 18 years of age or older
- Performance status of 0 or 1
- Use of an effective means of contraception in subjects of child-bearing potential
- Normal organ function as described in the protocol
Exclusion Criteria:
- Any prior cytotoxic chemotherapy or radiation for the current breast cancer
- HER2-negative ipsilateral breast recurrence, unless prior treatment consisted of
excision alone for DCIS or breast-conserving treatment and hormonal therapy for DCIS
or invasive cancer
- Life expectancy of less than 12 weeks
- Current, recent, or planned participation in an experimental durg study other than a
Genentech-sponsored bevacizumab cancer study
- Renal dysfunction for which exposure to cisplatin would require dose modifications
- Steroid dependent asthma
- Peripheral neuropathy of any etiology that exceeds grade 1
- Uncontrolled diabetes
- History of malignancy treated without curative intent
- Any other pre-existing medical condition that would represent toxicity in excess of
grade 1
- Inadequately controlled hypertension
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- NYHA Grade II or greater congestive hear failure
- History of myocardial infarction or unstable angina within 12 months prior to study
enrollment
- Any history of stroke or transient ischemic attack at any time
- Known CNS disease
- Significant vascular disease
- Symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 21 days
prior to study enrollment
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
within 6 months prior to study enrollment
- Serious, non-healing wound, ulcer or bone fracture
- Proteinuria at screening
- Known hypersensitivity to any component of bevacizumab
- Pregnant or lactating
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the pathologic complete response rate after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Paula D. Ryan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
06-202
NCT ID:
NCT00580333
Start Date:
September 2007
Completion Date:
December 2013
Related Keywords:
- Breast Cancer
- ER negative
- PR negative
- HER-2 negative
- Breast Neoplasms
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
