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Active Clinical Trials

A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer

Active NCT:
03493854
Allegheny General Hospital
Allegheny General Hospital

Category:
Cancer - Breast
Sponsor: 
Hoffmann-La Roche
Contact: 

For more information, please contact Dawn Kolar by telephone at 412-359-8162 or Dawn.Kolar@ahn.org or Ashley Young by telephone at 412-359-6458 or Ashley.Young@ahn.org.

A Phase III, Randomized, Multicenter, Open-Label, Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination with Chemotherapy in Patients with Her2-Positive Early Breast Cancer

Purpose: 

This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting.

Inclusion Criteria:

Ability to comply with the study protocol, in the investigator's judgment

Female and male patients with Stage II - IIIC (T2-T4, N0-N3, M0), locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer

Primary tumor >2 cm in diameter, or node-positive

HER2-positive breast cancer confirmed by a central laboratory prior to study enrollment. HER2-positive status will be determined based on pretreatment breast biopsy material.

Hormone receptor status of the primary tumor, centrally confirmed

Patient agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy

Availability of formalin-fixed, paraffin-embedded tumor tissue block for central confirmation of HER2 and hormone receptor status and additional biomarker research

Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55% measured by echocardiogram or multiple-gated acquisition scan

For women of childbearing potential (WOCBP) who are sexually active: agreement to remain abstinent or use one highly effective non-hormonal contraceptive method with a failure rate of < 1% per year, or two effective non-hormonal contraceptive methods during the treatment period and for 7 months after the last dose of HER2-targeted therapy

For men: men must remain abstinent or use a condom with a spermicidal product during the treatment period and for 7 months after the last dose of HER2-targeted therapy to avoid exposing the embryo. Men must refrain from donating sperm during this same period.

A negative serum pregnancy test must be available prior to randomization for WOCBP, unless they have undergone surgical sterilization

No major surgical procedure unrelated to breast cancer within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment

Exclusion Criteria:

Stage IV (metastatic) breast cancer

Patients with a history of invasive breast cancer

Patients with a history of concurrent or previously treated non-breast malignancies except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix, colon, and skin

Patients who have received any previous systemic therapy for treatment or prevention of breast cancer, or radiation therapy for treatment of cancer

Patients who have a past history of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for its treatment or radiation therapy to the ipsilateral breast

Patients with high-risk for breast cancer who have received chemo-preventative drugs in the past are not allowed to enter the study

Patients with multicentric breast cancer, unless all tumors are HER2-positive

Patients with bilateral breast cancer

Patients who have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes

Axillary lymph node dissection prior to initiation of neoadjuvant therapy

Sentinel lymph node biopsy prior to neoadjuvant therapy

Treatment with any investigational drug within 28 days prior to randomization

Serious cardiac illness or medical conditions

Inadequate bone marrow function, renal function or impaired liver function

Current severe, uncontrolled systemic disease that may interfere with planned treatment

Pregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the last dose of HER2-targeted therapy

Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study

Known active liver disease, for example, active viral hepatitis infection, autoimmune hepatic disorders, or sclerosing cholangitis

Concurrent, serious, uncontrolled infections, or known infection with HIV

Known hypersensitivity to study drugs, excipients, and/or murine proteins

Current chronic daily treatment with corticosteroids

History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer

History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease, coronary heart disease, clinically significant electrolyte abnormalities, or family history of sudden unexplained death or long QT syndrome