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

A Randomized Multicenter, Double-blind, Placebo-controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-positive Primary Breast Cancer (USON TOC4939G)

Study Description:

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).

Inclusion Criteria:

» Adult patients. >/= 18 years of age
» Non-metastatic primary invasive HER2-positive carcinoma of the breast that is adequately excised, and that is either node-positive (except T0) or node-negative but with presence of at least one risk factor as defined by the protocol
» Eastern Cooperative Oncology Group (ECOG) performance status </=1
» The interval between definitive surgery for breast cancer and randomization must be at least 3 weeks but no more than 7 weeks and the patient must be willing and able to start treatment within 1 week of randomization
» Known hormone receptor status (estrogen receptor and progesterone receptor)
» Baseline LVEF >/= 55%
» 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

Exclusion Criteria:

» History of any prior (ipsi- and/or contralateral) invasive 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
» Any "clinical" T4 tumor as defined by TNM, including inflammatory breast cancer
» Any previous systemic chemotherapy for cancer or radiotherapy for cancer
» Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
» Concurrent anti-cancer treatment in another investigational trial
» Serious cardiac or cardiovascular disease or condition
» Pregnant or lactating women


Texas Oncology - Baylor Regional Medical Center at Plano
4708 Alliance Blvd., Suite 150
Plano , TX 75093

Texas Oncology - Baylor Charles A. Sammons Cancer Center
3410 Worth Street
Dallas , TX 75246

Texas Oncology - Baylor All Saints Medical Center at Fort Worth
1400 Eighth Avenue
Fort Worth , TX 76104

Texas Oncology - Baylor Medical Center at Garland
2300 Marie Curie Blvd.
Garland , TX 75042

Lead Principal Investigator:

Manish Gupta, MD (Plano and Garland); Cynthia Osborne, MD (Dallas); Sanjay Oommen, MD (Fort Worth)

This trial is no longer available for enrollment.

Last update: December 27, 2012
† Baylor Research Institute and Texas Oncology are not affiliated. Each reviews, approves, and conducts clinical trials independently. Their clinical trials are listed together on this website for the convenience of patients.