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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

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


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 node-positive (except T0)

- Eastern Cooperative Oncology Group (ECOG) performance status
- 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.

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Invasive disease-free survival (IDFS)

Outcome Time Frame:

up to 13 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

BO25126

NCT ID:

NCT01358877

Start Date:

November 2011

Completion Date:

November 2023

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Bettendorf, Iowa  52722
Alexandria, Minnesota  56308
Albany, Georgia  31701
Great Falls, Montana  59405
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
McLean, Virginia  22101
Little Rock, Arkansas  72205-7199
Kansas City, Kansas  66160
Scarborough, Maine  04074
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Metairie, Louisiana  70006
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
Milwaukee, Wisconsin  
Charleston, South Carolina  
Lebanon, New Hampshire  
Charleston, West Virginia  25304
Providence, Rhode Island  02908
Washington, District of Columbia  
Jackson, Mississippi  
Sioux Falls, South Dakota  
Bismarck, North Dakota  58501
Salt Lake City, Utah  84112
Coeur D'alene, Idaho  83814