A Study of Pertuzumab in Addition to Chemotherapy and Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With HER2-Positive Primary Breast Cancer

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIITreatment18 and overBO25126
NCI-2012-00351, 2010-022902-41, BIG 04-11, TOC4939G, NCT01358877

Trial Description

Summary

This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and

efficacy of pertuzumab in addition to chemotherapy plus Herceptin (trastuzumab) as adjuvant

therapy in patients with operable HER2-positive primary breast cancer. After surgery,

patients will be randomized to receive either pertuzumab or placebo intravenously (iv) every

3 weeks for one year, in addition to 6-8 cycles of chemotherapy and 1 year of Herceptin

(trastuzumab) iv every 3 weeks. Anticipated time on study treatment is 52 weeks. This study

will be carried out in collaboration with the Breast International Group (BIG).

Eligibility Criteria

Inclusion Criteria:

Women of childbearing potential and male participants with partners of childbearing

potential must agree to use effective contraception (as defined by the protocol) by

the patient and/or partner for the duration of the study treatment and for at least 6

months after the last dose of study drug

Baseline LVEF >/= 55%

Known hormone receptor status (estrogen receptor and progesterone receptor)

The interval between definitive surgery for breast cancer and the first dose of

chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy

must be administered within 7 days of randomization or on Day 56, whichever occurs

first.

Eastern Cooperative Oncology Group (ECOG) performance status </=1

Non-metastatic primary invasive HER2-positive carcinoma of the breast that is

adequately excised and that is node-positive (except T0)

Adult patients. >/= 18 years of age

Exclusion Criteria:

Pregnant or lactating women

Serious cardiac or cardiovascular disease or condition

Concurrent anti-cancer treatment in another investigational trial

Prior use of anti-HER2 therapy for any reason or other prior biologic or

immunotherapy for cancer

Any previous systemic chemotherapy for cancer or radiotherapy for cancer

Any "clinical" T4 tumor as defined by TNM, including inflammatory breast cancer

History of non-breast malignancies within the 5 years prior to study entry, except

for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in

situ, and basal cell and squamous cell carcinomas of the skin

History of any prior (ipsi- and/or contralateral) invasive breast cancer

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

F Hoffmann-La Roche Limited

  • Breast International Group
  • Genentech Inc.

Trial Sites

U.S.A.

Arizona
Scottsdale

Mayo Clinic in Arizona

Donald Wallace Northfelt
Principal Investigator

Florida
Jacksonville

Mayo Clinic in Florida

Edith A. Perez
Principal Investigator

New York
New York

Memorial Sloan-Kettering Cancer Center

Chau Thanh Dang
Principal Investigator

Pennsylvania
Pittsburgh

University of Pittsburgh Cancer Institute (UPCI)

Adam Matthew Brufsky
Principal Investigator

Texas
Dallas

UT Southwestern/Simmons Cancer Center-Dallas

Barbara Jean B. Haley
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01358877

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.