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A Phase II Trial of Preoperative Cisplatin and Bevacizumab in ER-, PR-, Her-2 Negative Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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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

- 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

- 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:


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:


Principal Investigator

Paula D. Ryan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2007

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • ER negative
  • PR negative
  • HER-2 negative
  • Breast Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617