A Study Comparing Kadcyla + Perjeta Treatment with Chemotherapy + Herceptin + Perjeta in Patients with HER2-Positive Breast Cancer.

Phase 1

• Conditions: HER2-positive, operable, locally advanced or inflammatory early breast cancer.; MedDRA version: 17.1Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: LLTClassification code 10072740Term: Locally advanced breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: LLTClassification code 10021974Term: Inflammatory breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-004879-38-IE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-14
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

- age = 18 years
- Histologically confirmed invasive breast cancer with a primary tumor size of > 2 cm
- HER2-positive breast cancer
- Patients with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) if all discrete lesions are sampled and centrally confirmed as HER2-positive
- Stage at presentation: cT2-cT4, cN0-cN3, cM0
- Known hormone receptor status of the primary tumor
- Patient agreement to undergo mastectomy or breastconserving surgery after neoadjuvant therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
-Adequate hematologic, renal and liver funciton
- Baseline LVEF = 55% measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA)
-Negative serum pregnancy test results for women of childbearing potential and for women who have experienced menopause onset < 12 months prior to randomization
-Documentation of hepatitis B virus and hepatitis C virus serology is required
- Effective contraception as defined by protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 368
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

- Stage IV (metastatic) breast cancer
- Patients who have received prior anti-cancer therapy for breast cancer except those patients with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated
exclusively with mastectomy. In case of prior history of LCIS/DCIS, >5 years must have passed from surgery until diagnosis of current breast cancer
- Patients with multicentric (multiple tumors involving more than 1 quadrant) or bilateral breast cancer
- Patients who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
- Axillary lymph node dissection or positive sentinel lymph node prior to start of neoadjuvant therapy.
- History of concurrent or previous non-breast malignancies except for appropriately treated (1) nonmelanoma skin cancer and (2) in situ carcinomas, including cervix, colon, and skin. A patient with previous invasive non-breast cancer is eligible provided he/she has been disease-free 5 years
- Treatment with any investigational drug within 28 days prior to randomization
- Current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 Grade = 2 peripheral neuropathy
- Cardiopulmonary dysfunction as defined by the protocol
- Any significant concurrent medical or surgical conditions or findings that would jeopardize the patient's safety or ability to complete the study
- Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to randomization
- Known hypersensitivity to study drugs, excipients and/or murine proteins
- Concurrent, serious, uncontrolled infections or known infection with HIV
- Any known active liver disease, e.g. due to HBC, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
- Pregnancy or breastfeeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified