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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
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
CompletedPhase 3
Sponsor: Hoffmann-La Roche
Conditions: Breast Cancer
Interventions: FEC Chemotherapy, Surgery, Docetaxel, Pertuzumab, Placebo
Countries: China, South Korea, Taiwan, Thailand
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.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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
Locations (23)
- Beijing, China
- Changchun, China
- Changchun, China
- Fuzhou, China
- Guangzhou, China
- Guangzhou, China
- Harbin, China
- Jinan, China
- Nanjing, China
- Shanghai, China
- Shanghai, China
- Zhejiang, China
- Zhengzhou, China
- Daegu, South Korea
- Gyeonggi-do, South Korea
- Seoul, South Korea
- New Taipei City, Taiwan
- Taichung, Taiwan
- Taipei, Taiwan
- Taipei, Taiwan
- Bangkok, Thailand
- Khon Kaen, Thailand
- Songkhla, Thailand