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Trial record 1 of 1 for:    NCT01491737
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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

December 6, 2011
April 4, 2017
February 17, 2012
May 13, 2016   (Final data collection date for primary outcome measure)
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) ]
Progression-free Survival [ Time Frame: Up to approximately 49 months ]
Complete list of historical versions of study NCT01491737 on ClinicalTrials.gov Archive Site
  • 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) ]
  • Overall Survival [ Time Frame: Up to approximately 49 months ]
  • Overall Response Rate [ Time Frame: Up to approximately 49 months ]
  • Clinical Benefit Rate [ Time Frame: Up to approximately 49 months ]
  • Duration of Response [ Time Frame: Up to approximately 49 months ]
  • Time to Response [ Time Frame: Up to approximately 49 months ]
  • Safety: Incidence of Adverse Events [ Time Frame: Up to approximately 49 months ]
  • Quality of Life: EQ-5D Questionnaire [ Time Frame: Up to approximately 49 months ]
Not Provided
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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
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Breast Cancer
  • 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.
  • 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.

    Interventions:
    • Drug: Pertuzumab
    • Drug: Trastuzumab
    • Drug: Aromatase Inhibitor
    • Drug: Induction Chemotherapy
  • 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.

    Interventions:
    • Drug: Trastuzumab
    • Drug: Aromatase Inhibitor
    • Drug: Induction Chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
258
October 26, 2019
May 13, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   France,   India,   Italy,   Spain,   Turkey,   United Kingdom
 
 
NCT01491737
MO27775
2011-002132-10 ( EudraCT Number )
Not Provided
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP