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

Cancer
Breast Cancer

For Medical Professional
Results
Download
Print

Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 3

Study Identifier NCT02586025, YO28762

Condition Breast Cancer

Official Title A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate Pertuzumab in Combination With Docetaxel and Trastuzumab as Neoadjuvant Therapy, and Pertuzumab in Combination With Trastuzumab as Adjuvant Therapy After Surgery and Chemotherapy in Patients With Early-Stage or Locally Advanced HER2-Positive Breast Cancer

Study Summary

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 Criteria

Gender

All

Age

≥18 Years

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

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

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

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

Study results

LPS YO28762 PEONY Final Results August 2024 English (PDF, 0.3 MB)

LPS YO28762 PEONY Final Results August 2024 Thai (PDF, 0.4 MB)

LPS YO28762 PEONY Final Results August 2024 Taiwan Chinese (PDF, 0.9 MB)

LPS YO28762 PEONY Final Results August 2024 Korean (PDF, 0.5 MB)

LPS YO28762 PEONY Final Results August 2024 China Chinese (PDF, 0.6 MB)

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

Directly contact Roche for questions

Contact the hospital directly

Thank you

Something went wrong

Request a call back

Find participating medical centers and current study status in each of them

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

For the latest version of this information please go to www.forpatients.roche.com