Overview

This trial is active, not recruiting.

Condition breast neoplasms
Treatments docetaxel, nab-paclitaxel, paclitaxel, pertuzumab, trastuzumab
Phase phase 3
Target HER2
Sponsor Hoffmann-La Roche
Start date June 2012
End date September 2019
Trial size 1436 participants
Trial identifier NCT01572038, 2011-005334-20, MO28047

Summary

This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will receive pertuzumab and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first. Taxane chemotherapy can be either docetaxel, paclitaxel or nab-paclitaxel as per investigator's choice.
docetaxel
Participants may receive 'docetaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.
nab-paclitaxel
Participants may receive 'nab-paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.
paclitaxel
Participants may receive 'paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.
pertuzumab RO 43-68451
Participants will receive pertuzumab 840 milligrams (mg) IV on Day 1 or Day 2 of Cycle 1, followed by 420 mg IV on Day 1 or Day 2 of each subsequent 3-week cycle.
trastuzumab Herceptin
Participants will receive trastuzumab (Herceptin) 8 milligrams per kilogram (mg/kg) IV on Day 1 or Day 2 of Cycle 1, followed by 6 mg/kg IV on Day 1 or Day 2 of each subsequent 3-week cycle, administered in line with the respective product Information and/or recognized clinical practice guidelines.

Primary Outcomes

Measure
Percentage of Participants With AEs Leading to Study Treatment Interruption and Discontinuation
time frame: Baseline up to approximately 7 years 3 months
Percentage of Participants who Died, Reported by Cause of Death
time frame: Baseline up to approximately 7 years 3 months
Percentage of Participants with Congestive Heart Failure (CHF)
time frame: Baseline up to approximately 7 years 3 months
Percentage of Participants with Adverse Events (AEs) and Serious AEs (SAEs)
time frame: Baseline up to approximately 7 years 3 months
Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study
time frame: Screening, every 3 cycles (cycle length=3 weeks) prior to study drug administration during treatment period, 1 month post-treatment safety follow-up (approximately 7 years 3 months overall)
Time to Onset of the First Episode of CHF
time frame: Baseline up to approximately 7 years 3 months

Secondary Outcomes

Measure
Progression-Free Survival (PFS) as Assessed by Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
time frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months)
Overall Survival
time frame: Screening up to death due to any cause (up to approximately 7 years 3 months)
Percentage of Participants with Objective Response (Complete Response [CR] or Partial Response [PR]) Based on Best Confirmed Overall Response as Assessed by Investigator Based on RECIST v1.1
time frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months)
Percentage of Response with Clinical Benefit Response (CR, PR or Stable Disease [SD; for At Least 6 months] Based on Best Confirmed Overall Response as Assessed by Investigator Based on RECIST v.1.1
time frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months)
Duration of Response as Assessed by Investigator Based on RECIST v1.1
time frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months)
Time to Response Among Participants with Best Response of PR or CR as Assessed by Investigator Based on RECIST v1.1
time frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months)
Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores for Female Participants Only
time frame: Screening, every 3 cycles (cycle length=3 weeks) during treatment period, 1 and 3 months post-treatment safety follow-up (approximately 7 years 3 months overall)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection - HER2-positive breast cancer - Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2 - LVEF of at least 50 percent (%) Exclusion Criteria: - Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease - Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence less than or equal to (

Additional Information

Official title A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.