Phase 2
Completed N=416
A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.
Source: ClinicalTrials.gov NCT00545688 ↗Enrolled (actual)
416
Serious AEs
20.0%
Results posted
Jan 2016
Primary outcomePrimary: Percentage of Participants Achieving Pathological Complete Response (pCR) — 29.0; 45.8; 16.8; 24.0 percentage of participants — p=0.0094
Summary
This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Pathological Complete Response (pCR) |
29.0; 45.8; 16.8; 24.0 | 0.0094 sig |
| PRIMARY Percentage of Participants Achieving pCR by Breast Cancer Type |
23.4; 47.7; 16.9; 26.7; 14.3; 40.0 | — |
| PRIMARY Percentage of Participants Achieving pCR by Hormone Receptor Status |
20.0; 26.0; 5.9; 17.4; 36.8; 63.2 | — |
| PRIMARY Percentage of Participants Achieving pCR by Lymph Node Status |
21.5; 39.3; 11.2; 17.7; 7.5; 6.5 | — |
| PRIMARY Percentage of Participants Achieving pCR by Presence or Absence of Residual Intraductal Carcinoma (DCIS) / Intalobular Carcinoma (LCIS) |
16.8; 36.4; 9.3; 17.7; 12.1; 9.3 | — |
| SECONDARY Percentage of Participants Achieving Best Primary Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Disease Progression [PD]) During Neo-Adjuvant Treatment by X-Ray/Mammography |
18.3; 19.0; 13.1; 19.1; 49.3; 46.6 | — |
| SECONDARY Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During Neo-Adjuvant Period by X-Ray/Mammography |
18.3; 18.9; 12.7; 18.6; 49.3; 49.1 | — |
| SECONDARY Percentage of Participants Achieving Best Primary Breast Tumor Response (CR, PR, SD or PD) During Neo-Adjuvant Period by Clinical Examination |
23.2; 30.7; 16.7; 20.9; 56.6; 57.4 | — |
| SECONDARY Percentage of Participants Achieving Best Overall Response (CR, PR, SD or PD) During the Neo-Adjuvant Period by Clinical Examination |
21.6; 25.0; 11.2; 15.9; 59.8; 63.0 | — |
| SECONDARY Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by X-Ray/Mammography |
67.6; 65.5; 49.2; 66.0; 67.6; 67.9 | — |
| SECONDARY Percentage of Participants Achieving Clinical Response During Neo-Adjuvant Period by Clinical Examination |
79.8; 88.1; 67.6; 71.4; 81.4; 88.0 | — |
| SECONDARY Time to Clinical Response During Neo-Adjuvant Treatment Period |
6.3; 6.3; 6.9; 7.3 | — |
| SECONDARY Percentage of Participants With Progressive Disease During Neo-Adjuvant Treatment Period |
0.0; 0.9; 7.5; 2.1 | — |
| SECONDARY Percentage of Participants Achieving Breast Conserving Surgery For Whom Mastectomy Was Planned |
22.6; 23.2; 18.0; 31.7 | — |
| SECONDARY Percentage of Participants Who Were Progression Free and Disease Free |
82.2; 84.1; 74.8; 75.0; 82.5; 85.1 | — |
| SECONDARY Progression Free and Disease Free Survival |
NA; 71.0; NA; NA; NA; 67.2 | 0.2983 |
Eligibility Criteria
Inclusion Criteria
- female patients, >=18 years of age;
- locally advanced, inflammatory or early stage invasive breast cancer;
- HER2 positive (HER2+++ by IHC or FISH/CISH+).
Exclusion Criteria
- metastatic disease (Stage IV) or bilateral breast cancer;
- previous anticancer therapy or radiotherapy for any malignancy;
- other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
- insulin-dependent diabetes;
- clinically relevant cardiovascular disease.
Data sourced from ClinicalTrials.gov (NCT00545688). 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. Informational only — not medical advice.