Phase 2
Completed N=258
A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer
Source: ClinicalTrials.gov NCT01491737 ↗Enrolled (actual)
258
Serious AEs
29.5%
Results posted
Jun 2017
Primary outcomePrimary: Progression-Free Survival (PFS) — 18.89; 15.80; 20.63; 15.80 months — p=0.0070
Summary
This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line participants with HER2-positive and hormone receptor-positive advanced breast cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the investigator's discretion in combination with the assigned treatment arm. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal of consent, or death whichever occurs first.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
18.89; 15.80; 20.63; 15.80 | 0.0070 sig |
| SECONDARY Overall Survival (OS) |
NA; NA; 60.16; 57.17 | 0.5850 |
| SECONDARY Overall Response Rate (ORR) |
63.3; 55.7; 36.7; 44.3; 7.3; 0.9 | 0.2537 |
| SECONDARY Clinical Benefit Rate (CBR) |
68.8; 67.0; 7.3; 0.9; 56.0; 54.7 | 0.7743 |
| SECONDARY Duration of Response (DOR) |
27.10; 15.11; 27.40; 16.36 | 0.0181 sig |
| SECONDARY Time to Response (TTR) |
2.53; 3.91 | 0.5597 |
| SECONDARY Change From Baseline in Health-Related Quality of Life as Determined by European Quality of Life 5-Dimension (EQ-5D) Visual Analog Scale (VAS) Scores |
73.0; 72.8; 3.3; 1.9; 3.5; 0.5 | — |
| SECONDARY Overview of the Number of Participants With Adverse Events, Severity Determined According to NCI-CTCAE Version 4.03 |
122; 122; 72; 51; 35; 22 | — |
| SECONDARY Number of Participants Who Died Over the Course of the Study by Reported Cause of Death and Time of Death Relative to First or Last Dose of Study Treatment |
62; 57; 0; 0; 1; 0 | — |
| SECONDARY Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study |
63.8; 63.9; -1.0; -1.4; -2.3; -1.3 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with HER2-positive and hormone receptor-positive advanced metastatic or locally advanced breast cancer
- Post-menopausal status over 1 year
- HER2-positive as assessed by local laboratory on primary or metastatic tumor
- Hormone-receptor positive defined as estrogen receptor-positive and/or progesterone receptor-positive
- At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria In Solid Tumors Version 1.1
Exclusion Criteria
- Previous systemic non-hormonal anticancer therapy in the metastatic or locally advanced breast cancer setting
- Previous treatment with anti-HER2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting
- Disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment
- History of persistent Grade 2 or higher hematological toxicity according to National Cancer Institute-Common Toxicity Criteria Version 4.0
- Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months
- Other malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
- Clinical or radiographic evidence of central nervous system metastases or significant cardiovascular disease
Data sourced from ClinicalTrials.gov (NCT01491737). 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.