A Study of Kadcyla (Trastuzumab Emtansine) Plus Perjeta (Pertuzumab) Following Anthracyclines in Comparison With Herceptin (Trastuzumab) Plus Perjeta and a Taxane Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-positive Primary

Status: Recruiting
Phase:
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT01966471 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-590

 

This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of Kadcyla (trastuzumab emtansine, also known as T-DM1) in combination with Perjeta (pertuzumab) versus Herceptin (trastuzumab) in combination with Perjeta and a taxane as adjuvant therapy in patients with HER2-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, patients will receive either Kadcyla 3.6 mg/kg and Perjeta 420 mg intravenously (iv) every three weeks or Herceptin 6 mg/kg iv every three weeks in combination with Perjeta and a taxane. Anticipated time on HER2 targeted study treatment is up to 1 year.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Ian Krop, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Steven Come, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - Adult patients, >/= 18 years of age - Eastern Cooperative Oncology Group (ECOG) performance status </= 1 - Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable - HER2-positive breast cancer - Known hormone receptor status of the primary tumor - Adequately excised: patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy - Pathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer [UICC/AJCC] 7th edition): Eligible patients must have either: Node-positive disease (pN >/= 1), any tumor size except T0, and any hormonal receptor status, or Node-negative disease (pN0) with pathologic tumor size >2.0 cm by standard local assessment AND negative for ER and PR determined by a central pathology laboratory - Patients with synchronous bilateral invasive disease are eligible only if both lesions are HER2-positive - No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization - Baseline LVEF </= 55% measured by echocardiogram (ECHO; preferred) or multiple-gated acquisition (MUGA) scans - Female patients of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception. For male patients with partners of childbearing potential, one highly effective form of contraception or two effective forms of contraception must be used. Contraception must continue for the duration of study treatment and for 6 months after the last dose of study treatment Exclusion Criteria: - History of any prior (ipsi- and/or contralateral) invasive breast carcinoma - History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin - Any clinical T4 tumor as defined by tumor-node-metastasis classification in UICC/AJCC 7th edition, including inflammatory breast cancer - For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy (e.g., trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR anti-cancer radiation therapy (RT) (intraoperative radiotherapy as a boost at the time of primary surgery is acceptable) - Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any malignancy - History of DCIS and/or LCIS that was treated with any form of systemic chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed. Patients who had their DCIS/LCIS treated with surgery only and/or contralateral DCIS treated with radiation are allowed to enter the study - Patients with contraindication to RT while adjuvant RT is clinically indicated - Concurrent anti-cancer treatment in another investigational trial - Cardiopulmonary dysfunction as defined by protocol - Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease - Significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia - Myocardial infarction within 12 months prior to randomization - Uncontrolled hypertension o - Evidence of transmural infarction on ECG - Requirement for oxygen therapy - Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV - Any known active liver disease. For patients who are known carriers of HBV, active hepatitis B infection must be ruled out per local guidelines. - Inadequate hematologic, renal or liver function - Pregnant or lactating women - Hypersensitivity to any of the study medications or any of the ingredients or excipients of these medications, including hypersensitivity to benzyl alcohol - Chronic immunosuppressive therapies, including systemic corticosteroids
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