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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 (PERTAIN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01491737
First received: December 6, 2011
Last updated: April 4, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Breast Cancer
Drug: Pertuzumab
Drug: Trastuzumab
Drug: Aromatase Inhibitor
Drug: Induction Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Randomized, Two-Arm, Open-Label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab Plus an Aromatase Inhibitor in First Line Patients With HER2-Positive and Hormone Receptor-Positive Advanced (Metastatic or Locally Advanced) Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) [ Time Frame: Baseline up to approximately 8 years (assessed at Screening, every 3 cycles [21-day cycle] up to 36 months, thereafter every 6 cycles [21-day cycle] until disease progression or death) ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Baseline to death, lost to follow-up, or study termination (up to approximately 8 years) ]
  • Percentage of Participants With Objective Response of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 [ Time Frame: Baseline up to approximately 8 years (assessed at Screening, every 3 cycles [21-day cycle] up to 36 months, thereafter every 6 cycles [21-day cycle] until disease progression or death) ]
  • Percentage of Participants With Clinical Benefit Response of Confirmed CR or PR or Stable Disease (SD) According to RECIST v1.1 [ Time Frame: Baseline up to approximately 8 years (assessed at Screening, every 3 cycles [21-day cycle] up to 36 months, thereafter every 6 cycles [21-day cycle] until disease progression or death) ]
  • Duration of CR or PR According to RECIST v1.1 [ Time Frame: Baseline up to approximately 8 years (assessed at Screening, every 3 cycles [21-day cycle] up to 36 months, thereafter every 6 cycles [21-day cycle] until disease progression or death) ]
  • Time to CR or PR According to RECIST v1.1 [ Time Frame: Baseline up to approximately 8 years (assessed at Screening, every 3 cycles [21-day cycle] up to 36 months, thereafter every 6 cycles [21-day cycle] until disease progression or death) ]
  • Percentage of Participants with Adverse Events (AEs) or Serious AEs (SAEs) [ Time Frame: Screening up to approximately 8 years ]
  • Change From Baseline in Health-Related Quality of Life as Determined by European Quality of Life 5-Dimension (EQ-5D) Scores [ Time Frame: Baseline, every 3 cycles (21-day cycle), and every 3 months after treatment discontinuation (up to 24 months) ]

Enrollment: 258
Actual Study Start Date: February 17, 2012
Estimated Study Completion Date: October 26, 2019
Primary Completion Date: May 13, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pertuzumab, Trastuzumab, AI or Induction Chemotherapy

Participants will receive pertuzumab in combination with trastuzumab plus AI until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Participants may also receive induction chemotherapy (docetaxel every 3 weeks or paclitaxel weekly) up to the first 18-24 weeks of the treatment period at the investigator's discretion.

Drug: Pertuzumab
Participants will receive a loading dose of 840 milligrams (mg) as an intravenous infusion on Day 1 of first treatment cycle, followed by 420 mg on Day 1 or Day 2 of each subsequent 3-week cycle until disease progression or unacceptable toxicity.
Other Name: rhuMAb 2C4, Perjeta®
Drug: Trastuzumab
Participants will receive a loading dose of 8 milligrams per kilogram (mg/kg) as an intravenous infusion on Day 1 or 2 of first treatment cycle, followed by 6 mg/kg on Day 1 or Day 2 of each subsequent treatment 3-week cycles until disease progression or unacceptable toxicity.
Other Name: rhuMAb HER2, Herceptin®
Drug: Aromatase Inhibitor
Participants will receive 1 mg anastrozole or 2.5 mg letrozole orally once daily.
Drug: Induction Chemotherapy
Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period will receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective pertuzumab and/or trastuzumab infusions at the investigator's discretion.
Active Comparator: Trastuzumab, AI or Induction Chemotherapy

Participants will receive trastuzumab plus AI until predefined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Participants may also receive induction chemotherapy (docetaxel every 3 weeks or paclitaxel weekly) up to the first 18-24 weeks of the treatment period at the investigator's discretion.

Drug: Trastuzumab
Participants will receive a loading dose of 8 milligrams per kilogram (mg/kg) as an intravenous infusion on Day 1 or 2 of first treatment cycle, followed by 6 mg/kg on Day 1 or Day 2 of each subsequent treatment 3-week cycles until disease progression or unacceptable toxicity.
Other Name: rhuMAb HER2, Herceptin®
Drug: Aromatase Inhibitor
Participants will receive 1 mg anastrozole or 2.5 mg letrozole orally once daily.
Drug: Induction Chemotherapy
Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period will receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective pertuzumab and/or trastuzumab infusions at the investigator's discretion.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491737

  Show 94 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01491737     History of Changes
Other Study ID Numbers: MO27775
2011-002132-10 ( EudraCT Number )
Study First Received: December 6, 2011
Last Updated: April 4, 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Pertuzumab
Trastuzumab
Hormones
Aromatase Inhibitors
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on May 25, 2017