Status:
COMPLETED
A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line pa...
Eligibility Criteria
Inclusion
- Participants with HER2-positive and hormone receptor-positive advanced metastatic or locally advanced breast cancer
- Post-menopausal status over 1 year
- HER2-positive as assessed by local laboratory on primary or metastatic tumor
- Hormone-receptor positive defined as estrogen receptor-positive and/or progesterone receptor-positive
- At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria In Solid Tumors Version 1.1
Exclusion
- Previous systemic non-hormonal anticancer therapy in the metastatic or locally advanced breast cancer setting
- Previous treatment with anti-HER2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting
- Disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment
- History of persistent Grade 2 or higher hematological toxicity according to National Cancer Institute-Common Toxicity Criteria Version 4.0
- Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months
- Other malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
- Clinical or radiographic evidence of central nervous system metastases or significant cardiovascular disease
Key Trial Info
Start Date :
February 17 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2019
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT01491737
Start Date
February 17 2012
End Date
November 14 2019
Last Update
October 28 2020
Active Locations (82)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
Ironwood Cancer TX & Rsch Ctrs
Chandler, Arizona, United States, 85224
3
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
4
Comprehensive Blood & CA Ctr; Research
Bakersfield, California, United States, 93309