Phase 3
N=329
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
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02586025 ↗Enrolled (actual)
329
Serious AEs
15.9%
Results posted
Jan 2019
Primary outcome: Primary: Percentage of Participants With Total Pathologic Complete Response (tpCR) as Assessed by the Independent Review Committee (IRC) — 39.3; 21.8 percentage of participants — p=0.0014
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- FEC Chemotherapy (Drug); Surgery (Procedure); Docetaxel (Drug); Pertuzumab (Drug); Placebo (Drug); Trastuzumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Total Pathologic Complete Response (tpCR) as Assessed by the Independent Review Committee (IRC) |
39.3; 21.8 | 0.0014 sig |
| SECONDARY Percentage of Participants With tpCR as Assessed by the Local Pathologist |
39.3; 20.9 | 0.0008 sig |
| SECONDARY Percentage of Participants With Breast Pathologic Complete Response (bpCR), Defined as ypT0/is According to the AJCC Staging System as Assessed by the IRC |
42.0; 23.6 | 0.0010 sig |
| SECONDARY Percentage of Participants With bpCR as Assessed by the Local Pathologist |
41.6; 22.7 | 0.0006 sig |
| SECONDARY Percentage of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) During Cycles 1-4, According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
11.0; 10.0; 77.6; 68.2; 8.2; 19.1 | — |
| SECONDARY Percentage of Participants With an Objective Response (CR or PR) During Cycles 1-4, According to RECIST Version 1.1 |
88.6; 78.2 | 0.0125 sig |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Event-Free Survival (EFS) at 1, 3, and 5 Years |
98.62; 90.46; 88.85; 79.68; 84.80; 73.70 | 0.0140 sig |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Disease-Free Survival (DFS) at 1, 3, and 5 Years |
97.55; 92.08; 90.09; 81.10; 85.99; 75.02 | 0.0140 sig |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Overall Survival (OS) at 1, 3, and 5 Years |
99.54; 100.00; 97.01; 90.99; 93.86; 89.97 | 0.1181 |
| SECONDARY Percentage of Participants With at Least One Adverse Event (AE) During the Neoadjuvant Treatment Period |
97.7; 96.4 | — |
| SECONDARY Percentage of Participants With at Least One AE During the Adjuvant Treatment Period |
98.1; 98.1 | — |
| SECONDARY Percentage of Participants With at Least One Adverse Event During the Treatment-Free Follow-Up Period |
6.0; 7.3 | — |
| SECONDARY Percentage of Participants Who Experienced a Primary Cardiac Event |
0; 0 | — |
| SECONDARY Percentage of Participants Who Experienced a Secondary Cardiac Event |
0; 0 | — |
| SECONDARY Maximum Change From Baseline in LVEF |
-6.55; -6.20 | — |
| SECONDARY Change From Baseline in LVEF Over Time |
-0.62; 0.29; -1.02; 0.09; -0.96; 0.07 | — |
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
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 ( = 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
Data sourced from ClinicalTrials.gov (NCT02586025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.