Phase 3
Completed N=50
A Study of Pertuzumab and Trastuzumab Subcutaneous (SC) Treatment in Combination With a Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT02019277 ↗Enrolled (actual)
50
Serious AEs
54.0%
Results posted
Jul 2018
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs) and Serious AEs — 100.0; 54.0 percentage of participants
◆ Published Evidence
Emerging
19citations · ~3 / year
Results From the First Multicenter, Open-label, Phase IIIb Study Investigating the Combination of Pertuzumab With Subcutaneous Trastuzumab and a Taxane in Patients With HER2-positive Metastatic Breast Cancer (SAPPHIRE).
Summary
This open-label, multicenter, Phase IIIb study will assess the safety, tolerability and efficacy of a combination therapy of intravenous (IV) pertuzumab (Perjeta), trastuzumab (Herceptin) SC, and taxane chemotherapy (docetaxel, paclitaxel or nab-paclitaxel) as first-line therapy in participants with HER2-positive metastatic breast cancer (mBC). All participants will be treated with 3-week cycles of pertuzumab IV (840 milligrams [mg] first dose; subsequent doses of 420 mg) and trastuzumab SC (600 milligrams [mg]). The taxane treatment regimen will be determined by the investigator. Participants will continue therapy until disease progression, unacceptable toxicity, or the participant withdraws consent, whichever occurs first.
Linked Publications
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Results From the First Multicenter, Open-label, Phase IIIb Study Investigating the Combination of Pertuzumab With Subcutaneous Trastuzumab and a Taxane in Patients With HER2-positive Metastatic Breast Cancer (SAPPHIRE).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) and Serious AEs |
100.0; 54.0 | — |
| PRIMARY Percentage of Participants With AEs by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 Intensity Grades |
4.0; 32.0; 50.0; 12.0; 2.0 | — |
| PRIMARY Percentage of Participants With AEs Leading to Premature Discontinuation of Investigational Medicinal Products (IMPs) |
12.0 | — |
| PRIMARY Percentage of Participants With AEs of Suspected Cardiac Origin, by New York Heart Association Classification (NYHA) |
6.0; 4.0; 2.0; 0.0 | — |
| PRIMARY Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Below 50% |
8.0 | — |
| SECONDARY Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 |
73.3 | — |
| SECONDARY Percentage of Participants With PD (Assessed According to RECIST Version 1.1) or Death Due to Any Cause |
60.0 | — |
| SECONDARY Progression-free Survival (PFS) Assessed According to RECIST Version 1.1 |
17.02 | — |
| SECONDARY Percentage of Participants Who Died Due to Any Cause |
18.0 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Event-free Survival (EFS) Assessed According to RECIST Version 1.1 |
17.02 | — |
| SECONDARY Percentage of Participants Who Died During Receiving Second-Line of Treatment |
30.0 | — |
| SECONDARY OS During Second-Line of Treatment |
21.29 | — |
| SECONDARY Number of Participants Receiving Second-Line Treatment by Treatment Type |
8; 2; 2; 1; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- HER2-positive disease, with an immunohistochemistry score of 3+ or in situ hybridization (ISH)-positive on primary tumor or metastatic site
- Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic disease with at least one measurable lesion and/or non-measurable disease according to RECIST Version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 for participants who will receive paclitaxel or nab-paclitaxel chemotherapy and ECOG 0-1 for participants who will receive docetaxel chemotherapy
- LVEF of greater than or equal to (>=) 50 percent (%) measured by ECHO or MUGA scan before the first doses of pertuzumab and trastuzumab
- Previous use of either adjuvant or neoadjuvant anti-HER2 therapy is allowed
- Hormonal therapy will be allowed as per institutional guidelines. Hormonal therapy cannot be administered in combination with taxane therapy
Exclusion Criteria
- Previous systemic non-hormonal anticancer therapy for treatment of mBC
- History of other cancers. Participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively-treated cancers who have been disease-free for at least 5 years are eligible. Participants with previous ductal carcinoma in situ (DCIS) of the breast are also eligible for the study
- Pregnant or breastfeeding women. Positive serum pregnancy test in women of childbearing potential, premenopausal or less than 12 months of amenorrhea post-menopause, within 7 days before the first dose of pertuzumab and trastuzumab
- Current peripheral neuropathy of Grade 3 or greater (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.0)
- Radiographic evidence of central nervous system (CNS) metastases as assessed by computed tomography (CT) or magnetic resonance imaging (MRI), unless they have been treated and have been stable for at least 3 months and do not require ongoing corticosteroid treatment
- Participants with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
- Inadequate organ function
- Serious cardiac illness or medical conditions that would preclude the use of trastuzumab
- Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
- Concurrent enrollment in another clinical study using an investigational anti-cancer treatment, within 28 days before the first doses of trastuzumab and pertuzumab
Data sourced from ClinicalTrials.gov (NCT02019277) and the linked publication. 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.