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Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer (TROPiCS-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03901339
Recruitment Status : Completed
First Posted : April 3, 2019
Last Update Posted : November 18, 2023
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Sacituzumab Govitecan-hziy Drug: Eribulin Drug: Capecitabine Drug: Gemcitabine Drug: Vinorelbine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Least Two Prior Chemotherapy Regimens
Actual Study Start Date : May 8, 2019
Actual Primary Completion Date : October 20, 2023
Actual Study Completion Date : October 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sacituzumab Govitecan-hziy
Participants will receive sacituzumab govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 8 of a 21-day cycle.
 Drug: Sacituzumab Govitecan-hziy
Administered intravenously
Other Names:
  • IMMU-132
  • GS-0132
Active Comparator: Treatment of Physician's Choice (TPC)

Participants will receive TPC determined prior to randomization from one of the following single-agent treatment:

Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic)

  • Eribulin: 1.4 mg/m^2 for North American sites, 1.23 mg/m^2 for European sites) via IV on Days 1 and 8 of a 21-day cycle
  • Capecitabine: 1000-1250 mg/m^2 orally twice daily for 2 weeks followed by a 1-week rest period given as a 21-day cycle
  • Gemcitabine: 800-1200 mg/m^2 via IV on Days 1, 8, and 15 of each 28-day cycle or per institution
  • Vinorelbine: 25 mg/m^2 via IV on Day 1 weekly cycle per institution
 Drug: Eribulin
Administered intravenously per NCCN guidelines

Drug: Capecitabine
Administered orally per NCCN guidelines

Drug: Gemcitabine
Administered intravenously per NCCN guidelines

Drug: Vinorelbine
Administered intravenously per NCCN guidelines


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to approximately 3 years ]
    PFS is defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurs first) according to blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to approximately 3 years ]
    ORR is defined as the proportion of participants who have a best overall response of either Complete Remission (CR) or Partial Response (PR) that is confirmed ≥ 4 weeks later according to BICR using RECIST 1.1.

  2. Overall Survival (OS) [ Time Frame: Up to approximately 5 years ]
    OS is defined as the time from the date of randomization to the date of death from any cause.

  3. Duration of Response (DOR) [ Time Frame: Up to approximately 3 years ]
    DOR is defined as the time from the date a response was first documented until the date of the first documentation of disease progression or date of death (whichever occurs first).

  4. Clinical Benefit Rate (CBR) [ Time Frame: Up to approximately 3 years ]
    CBR is defined as best overall response of CR or PR or durable stable disease (duration of SD ≥ 6 months after randomization).

  5. Time to Deterioration (TTD) of Global Health Status/Quality of Life (QoL) Scale as Measured by European Organization for Research and Treatment of Cancer Quality of Life for Cancer Patients, Core Questionnaire Version 3.0 (EORTC QLQ-C30) [ Time Frame: Up to approximately 3 years ]

    The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).

    Deterioration is defined as greater than or equal to 10 points worsening from baseline in the global health status/QoL scale.


  6. TTD of Pain Score as Measured by EORTC QLQ-C30 [ Time Frame: Up to approximately 3 years ]

    The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).

    Deterioration is defined as greater than or equal to 10 points worsening from baseline in the pain score.


  7. TTD of Fatigue Score as Measured by EORTC QLQ-C30 [ Time Frame: Up to approximately 3 years ]

    The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).

    Deterioration is defined as greater than or equal to 10 points worsening from baseline in the fatigue score.


  8. Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 3 years ]
  9. Percentage of Participants Experiencing Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: Up to approximately 3 years ]
  10. Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities [ Time Frame: Up to approximately 3 years ]
  11. Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Baseline, Up to approximately 3 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Documented evidence of hormone receptor-positive human epidermal growth factor receptor 2 negative (HER2-negative) (hormonal receptor-positive (HR+)/HER2-) metastatic breast cancer (MBC) confirmed.

  • Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for metastatic disease:

    • At least 1 taxane in any setting.
    • At least 1 prior anticancer hormonal treatment in any setting.
    • At least 1 cyclin-dependent kinase inhibitor 4/6 in any setting.
  • Eligible for one of the chemotherapy options listed in the TPC arm.
  • Documented disease progression after the most recent therapy.
  • Adequate bone marrow function (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1,500 per mm^3, platelets ≥ 100,000 per mm^3).
  • Adequate renal function: calculated creatinine clearance ≥ 30 mL/minute according to the Cockcroft and Gault formula .
  • Adequate liver function (bilirubin ≤ 1.5 institutional upper limit of normal (IULN), or ≤ 3 IULN for individuals with documented Gilbert's syndrome, aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x IULN (in the case of liver metastases ≤ 5.0 x IULN)).
  • Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin (ß-hCG)).

Key Exclusion Criteria:

  • Previous treatment with topoisomerase 1 Inhibitors as a free form or as other formulations.
  • History of significant cardiovascular disease or clinically significant electrocardiogram (ECG) abnormality.
  • Active serious infection requiring antibiotics.
  • Any medical or other condition which, in the opinion of the Investigator, causes the individual to be medically unfit to receive sacituzumab govitecan or unsuitable for any reason.
  • Locally advanced MBC (stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901339


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03901339    
Other Study ID Numbers: IMMU-132-09
2018-004201-33 ( EudraCT Number )
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: https://www.gileadclinicaltrials.com/transparency-policy#Commitment

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Capecitabine
Vinorelbine
Sacituzumab govitecan
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs