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Sponsor: Hoffmann-La Roche
Conditions: Breast Cancer
Interventions: Pertuzumab, Trastuzumab, Aromatase Inhibitor, Induction Chemotherapy
Countries: United States, Brazil, France, India, Italy, Spain, Turkey (Türkiye), United Kingdom
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.
Sex: FEMALE
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * 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 Criteria: * 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
- Birmingham, Alabama, United States
- Chandler, Arizona, United States
- Hot Springs, Arkansas, United States
- Bakersfield, California, United States
- Denver, Colorado, United States
- Norwalk, Connecticut, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Marietta, Georgia, United States
- Wichita, Kansas, United States
- Marrero, Louisiana, United States
- Baltimore, Maryland, United States
- Bethesda, Maryland, United States
- St Louis, Missouri, United States
- Morristown, New Jersey, United States
- Voorhees Township, New Jersey, United States
- Lake Success, New York, United States
- Lake Success, New York, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Temple, Texas, United States
- São Paulo, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Besançon, France
- Bordeaux, France
- Brest, France
- Clermont-Ferrand, France
- Lyon, France
- + 52 more on CT.gov