Breast Cancer Clinical Trial
A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer
Summary
This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel. Participants in both cohorts will subsequently undergo surgical treatment and then resume pertuzumab and trastuzumab treatment.
Eligibility Criteria
Inclusion Criteria:
Male and female participants with locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer. Participants with inflammatory breast cancer must be able to have a core needle biopsy
Primary tumor greater than (>) 2 centimeters (cm) in diameter, or > 5 millimeters (mm) in diameter and node-positive
HER2-positive breast cancer confirmed by a central laboratory
Availability of tumor tissue specimen
Baseline LVEF greater than or equal to (>/=) 55%
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (=) 1
At least 4 weeks since major unrelated surgery, with full recovery
Women of childbearing potential and male participants with partners of childbearing potential must agree to use a "highly effective" non-hormonal form of contraception or two "effective" forms of non-hormonal contraception by the patient and/or partner. Contraception must continue for the duration of study treatment and for at least 7 months after the last dose of study treatment
Exclusion Criteria:
Metastatic disease (Stage IV) or bilateral breast cancer
Participants who have had an incisional biopsy of the primary tumor or the primary tumor excised
Prior breast or non-breast malignancy within 5 years prior to study entry, except for carcinoma in situ and basal cell and squamous cell carcinoma of the skin. Participants with malignancies occurring more than 5 years prior to study entry are permitted if curatively treated
Any previous systemic therapy (including chemotherapy, immunotherapy, HER2 targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer
Participants with a past history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) are not allowed to enter the study if they have received any systemic therapy for its treatment or radiation therapy to the ipsilateral breast (they are allowed to enter the study if treated with surgery alone)
High-risk participants who have received chemopreventive drugs in the past are not allowed to enter the study
Inadequate bone marrow, renal, or liver function
History or evidence of cardiovascular condition
Dyspnea at rest or other diseases that require continuous oxygen therapy
Severe, uncontrolled systemic disease
Participants with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications
Pregnancy or breast-feeding women
Participants who received any investigational treatment within 4 weeks of study start
Participants with known infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
Current chronic daily treatment with corticosteroids (dose >10 mg methylprednisolone or equivalent [excluding inhaled steroids])
Known hypersensitivity to any of the study drugs or excipients
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There are 80 Locations for this study
Mobile Alabama, 36604, United States
Greenbrae California, 94904, United States
San Francisco California, 94115, United States
Washington District of Columbia, 20007, United States
Washington District of Columbia, 20010, United States
Jacksonville Florida, 32256, United States
Marietta Georgia, 30060, United States
Pittsfield Massachusetts, 01201, United States
Minneapolis Minnesota, 55407, United States
Kansas City Missouri, 64111, United States
Hackensack New Jersey, 07601, United States
Morristown New Jersey, 07962, United States
Farmington New Mexico, 87401, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10011, United States
New York New York, 10065, United States
Rockville Centre New York, 11570, United States
Oklahoma City Oklahoma, 73120, United States
Amarillo Texas, 79106, United States
Salt Lake City Utah, 84112, United States
Roanoke Virginia, 24014, United States
Bellingham Washington, 98225, United States
Tacoma Washington, 98405, United States
Moncton New Brunswick, E1C 6, Canada
Barrie Ontario, L4M 6, Canada
Laval Quebec, H7M 3, Canada
Montreal Quebec, H3T1M, Canada
Montreal Quebec, H4J 1, Canada
Regina Saskatchewan, S4T 7, Canada
Herlev , 2730, Denmark
København Ø , 2100, Denmark
Vejle , 7100, Denmark
Le Mans , 72015, France
Lille , 59020, France
Lyon , 69373, France
Montpellier , 34070, France
Nancy , 54100, France
Nice , 06189, France
Paris , 75231, France
Rennes , 35042, France
Villejuif , 94805, France
Dresden , 01307, Germany
Göttingen , 37073, Germany
Langen , 63225, Germany
München , 81675, Germany
Neuruppin , 16816, Germany
Roma Lazio, 00161, Italy
Torino Piemonte, 10126, Italy
Lecce Puglia, 73100, Italy
Palermo Sicilia, 90146, Italy
Bagno a Ripoli Toscana, 50012, Italy
Grosseto Toscana, 58100, Italy
D.f. , 04980, Mexico
Monterrey , 64710, Mexico
Bergen , 5021, Norway
Oslo , 0450, Norway
Bialystok , 15-02, Poland
Kraków , 30-68, Poland
Otwock , 05-40, Poland
Poznan , 61-86, Poland
Lisboa , 1400-, Portugal
Lisboa , 1649-, Portugal
Loures , 2674-, Portugal
Porto , 4200-, Portugal
Badalona Barcelona, 08916, Spain
Córdoba Cordoba, 14004, Spain
La Coruña , 15009, Spain
Madrid , 28006, Spain
Madrid , 28034, Spain
Sevilla , 41009, Spain
Toledo , 45004, Spain
Bath , BA1 3, United Kingdom
Bournemouth , BH7 7, United Kingdom
London , SE1 9, United Kingdom
London , SW3 6, United Kingdom
New Castle Upon Tyne , NE7 7, United Kingdom
Oxford , OX3 7, United Kingdom
Peterborough , PE3 9, United Kingdom
Sutton , SM2 5, United Kingdom
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