Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel (PEONY)

Roche

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Pertuzumab; Procedure: Surgery; Drug: FEC Chemotherapy; Drug: Placebo; Drug: Trastuzumab; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02586025

YO28762

Details and patient eligibility

About

This is an Asia-Pacific regional, randomized, double-blind, multicenter trial designed to evaluate treatment with trastuzumab + pertuzumab + docetaxel compared with trastuzumab + placebo + docetaxel in chemotherapy-naïve participants with early-stage or locally advanced HER2-positive breast cancer. The anticipated treatment duration is approximately 17 months.

Enrollment: 329 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed invasive breast carcinoma with a primary tumor size of more than (>) 2 centimeters (cm) by standard local assessment technique
• Breast cancer stage at presentation: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, any N, M0)
• HER2-positive breast cancer confirmed by a Sponsor-designated central laboratory and defined as 3+ score by immunohistochemistry in > 10 percent (%) of immunoreactive cells or HER2 gene amplification (ratio of HER2 gene signals to centromere 17 signals equal to or more than [>=] 2.0) by in situ hybridization
• Known hormone receptor status (estrogen receptor and/or progesterone receptor)
• Eastern Cooperative Oncology Group Performance Status equal to or less than (<=) 1
• Baseline left ventricular ejection fracture >= 55% measured by echocardiography (preferred) or multiple gated acquisition scan
• Negative serum pregnancy test

Exclusion criteria

• Stage IV metastatic breast cancer
• Inflammatory breast cancer
• Previous anti-cancer therapy or radiotherapy for any malignancy
• 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
• Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy
• Major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or from which the participant has not fully recovered
• Serious cardiac illness or medical condition
• Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
• Any abnormalities in liver, kidney or hematologic function laboratory tests immediately prior to randomization
• Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol
• Pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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329 participants in 2 patient groups

Trastuzumab, Pertuzumab, and Chemotherapy

Experimental group

Description:

Prior to surgery: trastuzumab, pertuzumab, and docetaxel for 4 cycles (1 cycle = 21 days). After surgery/chemotherapy with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC): trastuzumab and pertuzumab up to 1 year total.

Treatment:

Drug: Docetaxel

Drug: Pertuzumab

Drug: FEC Chemotherapy

Procedure: Surgery

Drug: Trastuzumab

Trastuzumab, Placebo, and Chemotherapy

Experimental group

Description:

Prior to surgery: trastuzumab, placebo, and docetaxel for 4 cycles (1 cycle = 21 days). After surgery/FEC chemotherapy: trastuzumab and placebo up to 1 year total.

Treatment:

Drug: Docetaxel

Drug: Placebo

Drug: FEC Chemotherapy

Procedure: Surgery

Drug: Trastuzumab