Preoperative Cisplatin and Bevacizumab in ER-, PR-, HER2 Negative Breast Cancer

NCT00580333 | Completed Phase 2 Results DMC

• 2 other identifiers: 06-202AVF36335
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to find out what effect taking cisplatin in combination with bevacizumab before surgery and then standard chemotherapy plus bevacizumab after surgery will have on participants with Estrogen Receptor (ER) negative, Progesterone Receptor (PR) negative and Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer. Cisplatin is used to destroy cancer cells in many types of cancers, and has shown to be effective and have manageable side effects. Bevacizumab is an antibody, which is a protein that attacks a foreign substance in the body. Bevacizumab slows or stops cell growth in cancerous tumors by decreasing the blood supply to the tumors.

Conditions

Breast Cancer

Keywords

ER negative; PR negative; HER2 negative

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer.

  The goal of this measure was to determine the pathologic complete response rate (Miller-Payne (MP) score 5) after preoperative therapy with cisplatin and bevacizumab in ER-, PR-, HER2-negative early breast cancer.

  2 years

Secondary Outcomes (3)

• Clinical Overall and Complete Response Rates After Preoperative Therapy With Cisplatin and Bevacizumab

  2 years

• Toxicity of Administering Bevacizumab in Combination With Standard Adjuvant Chemotherapy.

  2 years

• Patients With Miller-Payne (MP) Score 3, 4, or 5 Response

  2 years

Study Arms (1)

Cisplatin/Avastin

EXPERIMENTAL

Cisplatin 75mg/m2 every 3 weeks, neoadjuvant bevacizumab 15mg/m2 every 3 weeks, neoadjuvant doxorubicin, adjuvant (optional) cyclophosphamide , adjuvant (optional) paclitaxel, adjuvant (optional)

Drug: cisplatin; Drug: bevacizumab; Drug: doxorubicin; Drug: cyclophosphamide; Drug: paclitaxel

Interventions

cisplatin DRUG

Preoperatively: Given intravenously on day one of the treatment cycle (once every 3 weeks) for four cycles

Also known as: platinol

Cisplatin/Avastin

bevacizumab DRUG

Preoperatively: Given intravenously on day 1 of the treatment cycle (once every three weeks) for three cycles Postoperatively: Intravenously for four 2-week cycles (once every two weeks) and after the 8 weeks (study doctor will determine course of treatment) for an additional four 2-week cycles with or with out paclitaxel

Also known as: Avastin

Cisplatin/Avastin

doxorubicin DRUG

Postoperative: Given intravenously for four 2-week cycles

Also known as: adriamycin

Cisplatin/Avastin

cyclophosphamide DRUG

Postoperative: Given intravenously for four two-week cycles

Also known as: cytoxan

Cisplatin/Avastin

paclitaxel DRUG

Postoperative: 8 weeks after postoperative chemotherapy regimen (study doctor will determine course of treatment) paclitaxel for four 2-week cycles (once every two weeks)

Also known as: taxol

Cisplatin/Avastin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All tumors must be ER-, PR- and HER2-negative
• Clinical stage T2 or T3, N0-3, M0. 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.
• years of age or older
• Performance status (PS) 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

You may not qualify if:

• Any prior cytotoxic chemotherapy or radiation for the current breast cancer
• HER2-negative ipsilateral breast recurrence, unless prior treatment consisted of excision alone for ductal carcinoma in situ (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
• New York Heart Association (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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Brigham and Women's Hospital: collaborator
• Genentech, Inc.: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cisplatin; Bevacizumab; Doxorubicin; Cyclophosphamide; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Steven Isakoff
• Organization: Massachusetts General Hospital

sisakoff@partners.org

617 726 6500

Study Officials

• Paula D. Ryan, MD

  Texas Oncology-The Woodlands

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Steven Isakoff, MD, PhD

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 24, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2020
• Last Updated: May 26, 2021
• Results First Posted: March 31, 2017

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)