Breast Cancer Clinical Trial
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
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 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.
Eligibility Criteria
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
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There are 80 Locations for this study
Birmingham Alabama, 35249, United States
Chandler Arizona, 85224, United States
Hot Springs Arkansas, 71913, United States
Bakersfield California, 93309, United States
Denver Colorado, 80220, United States
Norwalk Connecticut, 06856, United States
Miami Florida, 33176, United States
Atlanta Georgia, 30341, United States
Marietta Georgia, 30060, United States
Wichita Kansas, 67214, United States
Marrero Louisiana, 70072, United States
Baltimore Maryland, 21237, United States
Bethesda Maryland, 20817, United States
Saint Louis Missouri, 63110, United States
Morristown New Jersey, 07960, United States
Voorhees New Jersey, 08043, United States
Lake Success New York, 11042, United States
Lake Success New York, 11042, United States
Pittsburgh Pennsylvania, 15232, United States
Houston Texas, 77030, United States
Temple Texas, 76508, United States
Sao Paulo SP, 01246, Brazil
Sao Paulo SP, 01317, Brazil
Sao Paulo SP, 03102, Brazil
São Paulo SP, CEP 0, Brazil
Besancon , 25030, France
Bordeaux , 33000, France
Brest , 29609, France
Clermont Ferrand , 63011, France
Lyon , 69337, France
Nantes , 44202, France
Nice , 06189, France
Senlis , 60309, France
Toulouse , 31076, France
Vandoeuvre-les-nancy , 54519, France
New Delhi Delhi, 11007, India
Bangalore Karnataka, 56002, India
Mumbai Maharashtra, 40002, India
Chennai , 60003, India
Pune , 411 0, India
Napoli Campania, 80131, Italy
Napoli Campania, 80131, Italy
Bologna Emilia-Romagna, 40138, Italy
Parma Emilia-Romagna, 43100, Italy
Pordenone Friuli-Venezia Giulia, 33170, Italy
Sora Lazio, 03039, Italy
Castellanza Lombardia, 21053, Italy
Milano Lombardia, 20133, Italy
Pavia Lombardia, 27100, Italy
Bari Puglia, 70124, Italy
Brindisi Puglia, 72100, Italy
Lecce Puglia, 73100, Italy
Catania Sicilia, 95122, Italy
Firenze Toscana, 50139, Italy
Prato Toscana, 59100, Italy
Badalona Barcelona, 08916, Spain
Castellon de La Plana Castellon, 12002, Spain
Córdoba Cordoba, 14004, Spain
San Sebastian Guipuzcoa, 20014, Spain
San Sebastian Guipuzcoa, 20080, Spain
Barcelona , 08003, Spain
Caceres , 10003, Spain
La Coruña , 15006, Spain
La Coruña , 15009, Spain
Lerida , 25198, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Murcia , 30120, Spain
Sevilla , 41009, Spain
Valencia , 46010, Spain
Zaragoza , 50009, Spain
Ankara , 06100, Turkey
Ankara , 06490, Turkey
Izmir , 35100, Turkey
Malatya , 44280, Turkey
Brighton , BN2 5, United Kingdom
Coventry , CV2 2, United Kingdom
Glasgow , G12 0, United Kingdom
London , SE18 , United Kingdom
Portsmouth , PO6 3, United Kingdom
Scarborough , YO12 , United Kingdom
Sheffield , S10 2, United Kingdom
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