Clareo Health | 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
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
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Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
