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A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

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ClinicalTrials.gov Identifier: NCT04546009
Recruitment Status : Recruiting
First Posted : September 11, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE September 8, 2020
First Posted Date  ICMJE September 11, 2020
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE October 9, 2020
Estimated Primary Completion Date April 26, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2020)
Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1 [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 78 months) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2021)
  • Overall Survival [ Time Frame: From randomization to death from any cause (up to 78 months) ]
  • Objective Response Rate, as Determined by the Investigator According to RECIST v1.1 [ Time Frame: From randomization until disease progression or death (up to 78 months) ]
    The objective response rate is defined as the percentage of participants with a complete response or partial response on two consecutive occasions at least (≥)4 weeks apart.
  • Duration of Response, as Determined by the Investigator According to RECIST v1.1 [ Time Frame: From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to 78 months) ]
  • Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1 [ Time Frame: From randomization until disease progression or death (up to 78 months) ]
    The clinical benefit rate is defined as the percentage of participants with stable disease for ≥24 weeks or a complete response or partial response.
  • Time to Deterioration in Pain Level, Defined as the Time to First Documented ≥2-Point Increase from Baseline in the 'Worst Pain' Item from the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire [ Time Frame: From Baseline until treatment discontinuation (up to 78 months) ]
  • Time to Deterioration in Pain Presence and Interference, Defined as the Time to First Documented ≥10-Point Increase from Baseline in the EORTC QLQ-C30 Linearly Transformed Pain Scale Score [ Time Frame: From Baseline until treatment discontinuation (up to 78 months) ]
    EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire
  • Time to Deterioration in Physical Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Physical Functioning Scale Score [ Time Frame: From Baseline until treatment discontinuation (up to 78 months) ]
  • Time to Deterioration in Role Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Role Functioning Scale Score [ Time Frame: From Baseline until treatment discontinuation (up to 78 months) ]
  • Time to Deterioration in Global Health Status and Quality of Life (GHS/QoL), Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed GHS/QoL Scale Score [ Time Frame: From Baseline until treatment discontinuation (up to 78 months) ]
  • Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) [ Time Frame: From treatment initiation until 30 days after the final dose of study treatment (up to 78 months) ]
  • Number of Participants with Vital Sign Abnormalities Over the Course of the Study [ Time Frame: Baseline, Days 1 and 15 of Cycles 1 and 2, and Day 1 of each cycle thereafter until treatment discontinuation (1 cycle is 28 days) ]
    Vital signs include respiratory rate, pulse rate, and systolic and diastolic blood pressure while the participant is in a seated position, and temperature.
  • Plasma Concentration of Giredestrant at Specified Timepoints [ Time Frame: Days 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 8, and 16 (1 cycle is 28 days) ]
  • Plasma Concentration of Palbociclib at Specified Timepoints [ Time Frame: Days 1 and 15 of Cycle 1 (1 cycle is 28 days) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2020)
  • Overall Survival [ Time Frame: From randomization to death from any cause (up to 78 months) ]
  • Objective Response Rate, as Determined by the Investigator According to RECIST v1.1 [ Time Frame: From randomization until disease progression or death (up to 78 months) ]
    The objective response rate is defined as the percentage of participants with a complete response or partial response on two consecutive occasions at least (≥)4 weeks apart.
  • Duration of Response, as Determined by the Investigator According to RECIST v1.1 [ Time Frame: From first occurrence of documented objective response to disease progression or death from any cause, whichever occurs first (up to 78 months) ]
  • Clinical Benefit Rate, as Determined by the Investigator According to RECIST v1.1 [ Time Frame: From randomization until disease progression or death (up to 78 months) ]
    The clinical benefit rate is defined as the percentage of participants with stable disease for ≥24 weeks or a complete response or partial response.
  • Time to Deterioration in Pain Level, Defined as the Time to First Documented ≥2-Point Increase from Baseline in the 'Worst Pain' Item from the Brief Pain Inventory-Short Form (BPI-SF) Questionnaire [ Time Frame: From Baseline until treatment discontinuation (up to 78 months) ]
  • Time to Deterioration in Pain Presence and Interference, Defined as the Time to First Documented ≥10-Point Increase from Baseline in the EORTC QLQ-C30 Linearly Transformed Pain Scale Score [ Time Frame: From Baseline until treatment discontinuation (up to 78 months) ]
    EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire
  • Time to Deterioration in Physical Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Physical Functioning Scale Score [ Time Frame: From Baseline until treatment discontinuation (up to 78 months) ]
  • Time to Deterioration in Role Functioning, Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed Role Functioning Scale Score [ Time Frame: From Baseline until treatment discontinuation (up to 78 months) ]
  • Time to Deterioration in Global Health Status and Quality of Life (GHS/QoL), Defined as the Time to First Documented ≥10-Point Decrease from Baseline in the EORTC QLQ-C30 Linearly Transformed GHS/QoL Scale Score [ Time Frame: From Baseline until treatment discontinuation (up to 78 months) ]
  • Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) [ Time Frame: From treatment initiation until 30 days after the final dose of study treatment (up to 78 months) ]
  • Number of Participants with Vital Sign Abnormalities Over the Course of the Study [ Time Frame: Baseline, Days 1 and 15 of Cycles 1 and 2, and Day 1 of each cycle thereafter until treatment discontinuation (1 cycle is 28 days) ]
    Vital signs include respiratory rate, pulse rate, and systolic and diastolic blood pressure while the participant is in a seated position, and temperature.
  • Plasma Concentration of GDC-9545 at Specified Timepoints [ Time Frame: Days 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 8, and 16 (1 cycle is 28 days) ]
  • Plasma Concentration of Palbociclib at Specified Timepoints [ Time Frame: Days 1 and 15 of Cycle 1 (1 cycle is 28 days) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
Official Title  ICMJE A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Brief Summary This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: Giredestrant
    Giredestrant is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
    Other Names:
    • GDC-9545
    • RO7197597
    • RG6171
  • Drug: Giredestrant-matched Placebo
    Giredestrant-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
  • Drug: Letrozole
    Letrozole 2.5 milligrams (mg) is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
  • Drug: Letrozole-matched Placebo
    Letrozole-matched placebo is taken orally once per day on Days 1-28 of each 28-day treatment cycle.
  • Drug: Palbociclib
    Palbociclib 125 mg is taken orally once per day on Days 1-21 of each 28-day treatment cycle.
  • Drug: LHRH Agonist
    Only premenopausal/perimenopausal and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
Study Arms  ICMJE
  • Experimental: Giredestrant + Letrozole-matched Placebo + Palbociclib
    Interventions:
    • Drug: Giredestrant
    • Drug: Letrozole-matched Placebo
    • Drug: Palbociclib
    • Drug: LHRH Agonist
  • Active Comparator: Letrozole + Giredestrant-matched Placebo + Palbociclib
    Interventions:
    • Drug: Giredestrant-matched Placebo
    • Drug: Letrozole
    • Drug: Palbociclib
    • Drug: LHRH Agonist
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2020)
978
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 18, 2027
Estimated Primary Completion Date April 26, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment
  • Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
  • Documented ER-positive tumor and HER2-negative tumor, assessed locally
  • Patients who have bilateral breast cancers which are both ER-positive and HER2-negative can be included in the study because the metastases are suitably targeted by the study treatments. If patients have bilateral tumors which are of different biomarker status, then proof of the ER and HER2 status of the metastases is required for study entry
  • No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease
  • Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months
  • Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
  • Eastern Cooperative Oncology Group Performance Status 0-1
  • Adequate organ function

Exclusion Criteria:

  • Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with an aromatase inhibitor (AI)
  • Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor
  • Prior treatment with a selective estrogen receptor degrader (SERD)
  • Prior treatment with tamoxifen is permitted, provided the patient did not experience disease recurrence within the first 24 months of treatment with tamoxifen
  • Treatment with any investigational therapy within 28 days prior to study treatment
  • Advanced, symptomatic, visceral spread that is at risk of life-threatening complications
  • Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
  • Active cardiac disease or history of cardiac dysfunction
  • Pregnant or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: BO41843 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Denmark,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   New Zealand,   Poland,   Portugal,   Russian Federation,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04546009
Other Study ID Numbers  ICMJE BO41843
2020-000119-66 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date April 2021

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