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
Completed · Phase 2
Conditions studied: Breast Cancer
In brief
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 participants with HER2-positive and hormone receptor-positive advanced breast cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the investigator's discretion in combination with the assigned treatment arm. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal of consent, or death whichever occurs first.
Key facts
- Study ID
- NCT01491737
- Run by
- Hoffmann-La Roche
- People needed
- 258
- Starts
- 2012-02-17
- Expected to finish
- 2019-11-14
- Last updated by the study team
- 2020-10-28
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ironwood Cancer TX & Rsch Ctrs — Chandler, Arizona, United States
- Genesis Cancer Center — Hot Springs, Arkansas, United States
- Comprehensive Blood & CA Ctr; Research — Bakersfield, California, United States
- Rocky Mountain Cancer Center - Denver — Denver, Colorado, United States
- Norwalk Hospital — Norwalk, Connecticut, United States
- Advanced Medical Specialties — Miami, Florida, United States
- Georgia Cancer Specialists - Northside — Atlanta, Georgia, United States
- Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital — Marietta, Georgia, United States
- Cancer Center of Kansas — Wichita, Kansas, United States
- Crescent City Rsrch Cnsrtm, LLC — Marrero, Louisiana, United States
- Weinberg CA Inst Franklin Sq — Baltimore, Maryland, United States
- Center For Cancer and Blood Disorders — Bethesda, Maryland, United States
- Washington University School of Medicine; Internal Medicine - Renal — St Louis, Missouri, United States
- Hematology Oncology Associates; Carol G. Simon Ctr — Morristown, New Jersey, United States
- Cooper Hospital; Hematology & Oncology — Voorhees Township, New Jersey, United States
- NS-Long Island Jewish Hlth Sys — Lake Success, New York, United States
- ProHEALTH Care Associates LLP — Lake Success, New York, United States
- UPMC Cancer Centers — Pittsburgh, Pennsylvania, United States
- Baylor College of Medicine; Lester & Sue Smith Breast Ctr — Houston, Texas, United States
- Scott and White Hospital; Cancer Center — Temple, Texas, United States
- Instituto do Cancer do Estado de Sao Paulo - ICESP — São Paulo, São Paulo, Brazil
- Hospital Perola Byington — São Paulo, São Paulo, Brazil
- Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia — São Paulo, São Paulo, Brazil
- Hospital Sao Jose — São Paulo, São Paulo, Brazil
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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