Phase 2
Completed N=400
A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer
Source: ClinicalTrials.gov NCT02132949 ↗Enrolled (actual)
400
Serious AEs
30.7%
Results posted
Apr 2017
Primary outcomePrimary: Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Neoadjuvant Treatment Period — 1.5; 0 percentage of participants
Summary
This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel. Participants in both cohorts will subsequently undergo surgical treatment and then resume pertuzumab and trastuzumab treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Neoadjuvant Treatment Period |
1.5; 0 | — |
| PRIMARY Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Neoadjuvant Treatment Period |
6.5; 2.0; 1.0; 0.5; 5.5; 1.5 | — |
| SECONDARY Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Adjuvant Treatment Period |
0; 0.5 | — |
| SECONDARY Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Adjuvant Treatment Period |
7.7; 10.5; 2.8; 3.2; 5.0; 7.4 | — |
| SECONDARY Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Treatment-Free Follow-Up Period |
0; 0.5 | — |
| SECONDARY Percentage of Participants With at Least One Left Ventricular Ejection Fraction (LVEF) Significant Decline, Defined as a Drop in LVEF of at Least 10 Percentage Points From Baseline and to Below 50%, During the Treatment-Free Follow-Up Period |
6.0; 3.5; 3.0; 1.0; 3.0; 2.5 | — |
| SECONDARY Overview of the Number of Participants With at Least One Adverse Event During the Neoadjuvant Period |
198; 198; 99; 108; 45; 52 | — |
| SECONDARY Overview of the Number of Participants With at Least One Adverse Event During the Adjuvant Period |
171; 171; 23; 40; 15; 17 | — |
| SECONDARY Overview of the Number of Participants With at Least One Adverse Event During the Treatment-Free Follow-Up Period |
3; 7; 2; 5; 3; 7 | — |
| SECONDARY Percentage of Participants Positive for Anti-Therapeutic Antibodies (ATAs) to Pertuzumab at Baseline and Anytime Post-Baseline |
1.6; 2.1; 4.6; 3.6 | — |
| SECONDARY Percentage of Participants With Total Pathologic Complete Response (tpCR), Evaluated After Surgery |
61.8; 60.7 | — |
| SECONDARY Percentage of Participants With Clinical Response as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 During the Neoadjuvant Treatment Period |
67.3; 60.2; 39.7; 23.9; 27.6; 36.3 | — |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Event-Free Survival (EFS) at 1 to 5 Years, Determined by the Investigator According to RECIST v1.1 |
98.47; 97.48; 95.80; 92.86; 93.58; 90.78 | — |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Invasive Disease-Free Survival (iDFS) at 1 to 4 Years, Determined by the Investigator According to RECIST v1.1 |
98.91; 96.34; 95.57; 94.25; 94.42; 91.06 | — |
| SECONDARY Kaplan-Meier Estimate of the Percentage of Participants Event-Free for Overall Survival (OS) at 1 to 5 Years |
99.48; 100.00; 98.96; 97.94; 97.86; 96.38 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female participants with locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer. Participants with inflammatory breast cancer must be able to have a core needle biopsy
- Primary tumor greater than (>) 2 centimeters (cm) in diameter, or > 5 millimeters (mm) in diameter and node-positive
- HER2-positive breast cancer confirmed by a central laboratory
- Availability of tumor tissue specimen
- Baseline LVEF greater than or equal to (>/=) 55%
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to ( 10 mg methylprednisolone or equivalent [excluding inhaled steroids])
- Known hypersensitivity to any of the study drugs or excipients
Data sourced from ClinicalTrials.gov (NCT02132949). 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.