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Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- MBC

Sponsor
Everest Medicines (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04639986
Collaborator
Iqvia Pty Ltd (Industry), Medidata Solutions (Industry), Parexel (Industry)
330
Enrollment
44
Locations
2
Arms
37.2
Anticipated Duration (Months)
7.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, randomized, multicenter Phase 3 study to compare the efficacy and safety of sacituzumab govitecan versus TPC in subjects with metastatic or locally recurrent inoperable HR+/HER2- MBC, after failure of at least 2, and no more than 4, prior chemotherapy regimens for metastatic disease.

Condition or Disease Intervention/Treatment Phase
  • Drug: sacituzumab govitecan (IMMU-132)
  • Drug: Eribulin Mesylate Injection
  • Drug: Capecitabine Oral Product
  • Drug: Gemcitabine Injection
  • Drug: Vinorelbine injection
 Phase 3

Detailed Description

Approximately 330 eligible subjects will be randomly allocated to one of the following 2 treatment arms in a 1:1 ratio:

Investigational Arm:

Sacituzumab Govitecan 10 mg/kg via IV injection administered on Day 1 and Day 8 (21-day cycle).

Control Arm:

Recommended doses and schedules as per NCCN guidelines (with dose modifications if too toxic).

Eribulin; Capecitabine; Gemcitabine; Vinorelbine Subjects will be treated until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
330 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Asian Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With HR+/ HER2- Metastatic Breast Cancer (MBC) Who Have Failed at Least 2 Prior Chemotherapy Regimens
Actual Study Start Date :
Nov 23, 2020
Anticipated Primary Completion Date :
Dec 14, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

Sacituzumab govitecan 10 mg/kg via IV injection administered on Days 1 and 8 of a 21-day cycle.

Drug: sacituzumab govitecan (IMMU-132)
Sacituzumab govitecan 10 mg/kg via IV injection administered on Days 1 and 8 of a 21-day cycle. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
Other Names:
  • Trodelvy

    		•
    Active Comparator: Arm B

    Recommended doses and schedules as per package insert depending on region. Eribulin (1.4 mg/m2 of eribulin mesylate or 1.23 mg/m2 of eribulin IV on Days 1 and 8 of a 21-day cycle) Capecitabine (1000 to 1250 mg/m2 PO twice daily on Days 1 to 14 of a 21-day cycle) Gemcitabine (800 to 1200 mg/m2 IV on Days 1, 8, and 15 of a 28-day cycle) Vinorelbine (25 mg/m2 IV on Day 1 weekly)

    Drug: Eribulin Mesylate Injection
    Eribulin is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
    Other Names:
  • Halaven

    • Drug: Capecitabine Oral Product
    Capecitabine is administered orally (PO) following recommended doses and regimens as per approved package inserts.
    Other Names:
  • Xeloda

    • Drug: Gemcitabine Injection
    Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
    Other Names:
  • Gemzar

    • Drug: Vinorelbine injection
    Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
    Other Names:
  • Navelbine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival (PFS) [within approximately 3 years]

      PFS measured from the date of randomization until the date of PD or death, whichever occurs earlier. Disease progression will be determined according to RECIST v 1.1 by an IRC.

    Secondary Outcome Measures

    1. Overall survival [OS] [4 years]

      Defined as from the date of randomization to death

    2. Objective response rate [ORR] by IRC [3 years]

      Objective response includes CR and PR

    3. Duration of response [DOR] by IRC [3 years]

      Defined as from the date of first onset of tumor response (CR or PR) to PD or death, whichever occurs earlier.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Female or male subjects aged ≥18 years at the time of signing the informed consent form

    • Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) MBC confirmed

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

    • Should have been previously treated with at least 1 taxane in any setting, at least 1 prior anticancer hormonal treatment in any setting

    • Eligible for one of the chemotherapy options listed in the TPC arm

    • Documented radiographic disease progression after the most recent therapy

    • Measurable disease by CT or MRI in accordance with RECIST v 1.1, bone-only disease is not measurable and is not permitted.

    • Adequate bone marrow function, hepatic and renal function

    • Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin [ß-hCG]

    Exclusion Criteria:

    • Previous treatment with Topoisomerase 1 Inhibitors as a free form or as other formulations

    • Subjects who have known brain metastases.

    • Have an active second malignancy within 3 years prior to providing informed consent

    • Subjects with active hepatitis B virus (HBV), or hepatitis C virus infection (measurable viral RNA load with polymerase chain reaction).

    • Active serious infection requiring systemic antibiotic use within 7 days before C1D1.

    • Patients with a history of an anaphylactic reaction to irinotecan.

    • Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

    • Known hypersensitivity or intolerance to either of the study treatments or any of the excipients.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Hospital Chinese Academy of Medical Science Beijing China
    2 Chinese PLA General Hospital Beijing China
    3 Peking University People's Hospital Beijing China
    4 Jilin Cancer Hospital Changchun China
    5 The First Hospital of Jilin University Changchun China
    6 Chongqing University Cancer Hospital Chengdu China
    7 West China Hospital, Sichuan University Chengdu China
    8 Fujian Medical University Union Hospital Fuzhou China
    9 Guangdong Provincial People's Hospital Guangzhou China
    10 Sun Yat Sen Memorial Hospital of Sun Yat sen University Guangzhou China
    11 Sun Yat-sen University Cancer Center Guangzhou China
    12 Sir Run run Shaw hospital Zhejiang University School of Medicine Hangzhou China
    13 Zhejiang Cancer Hospital Hangzhou China
    14 Anhui Provincial Hospital Hefei China
    15 The second Hospital of Anhui Medical University Hefei China
    16 Shandong Cancer Hospital Jinan China
    17 Yunnan Cancer Hospital Kunming China
    18 Linyi Cancer Hospital Linyi China
    19 Jiangsu Province Hospital Nanjing China
    20 Nanjing Drum Tower Hospital Nanjing China
    21 Shanghai General Hospital Shanghai China
    22 Liaoning Cancer Hospital & Institute Shenyang China
    23 Tianjin Medical University Cancer Institute & Hospital Tianjin China
    24 Hubei Cancer Hospital Wuhan China
    25 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan China
    26 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an China
    27 Henan Cancer Hospital Zhengzhou China
    28 Affiliated Tumor Hospital of Xinjiang Medical University Ürümqi China
    29 Dong-A University Hospital Busan Korea, Republic of
    30 Seoul National University Bundang Hospital Seongnam Korea, Republic of
    31 Asan Medical Center Seoul Korea, Republic of
    32 Korea University Anam Hospital Seoul Korea, Republic of
    33 Samsung Medical Center Seoul Korea, Republic of
    34 Seoul National University Hospital Seoul Korea, Republic of
    35 Severance Hospital Yonsei University Health System Seoul Korea, Republic of
    36 Ajou University Hospital Suwon Korea, Republic of
    37 Changhua Christian Medical Foundation Changhua Christian Hospital Changhua Taiwan
    38 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan
    39 China Medical University Hospital Taichung Taiwan
    40 National Cheng Kung University Hospital Tainan Taiwan
    41 National Taiwan University Hospital Taipei Taiwan
    42 Taipei Veterans General Hospital Taipei Taiwan
    43 Tri-Service General Hospital Taipei Taiwan
    44 Chang Gung Memorial Hospital, Linkou Taoyuan Taiwan

    Sponsors and Collaborators

    • Everest Medicines
    • Iqvia Pty Ltd
    • Medidata Solutions
    • Parexel

    Investigators

    • Study Director: Jack Chen, MD, Everest Medicines

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Everest Medicines
    ClinicalTrials.gov Identifier:
    NCT04639986
    Other Study ID Numbers:
    • EVER-132-002
    First Posted:
    Nov 23, 2020
    Last Update Posted:
    Apr 21, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Everest Medicines
    sacituzumab govitecan
    IMMU-132
    Unresectable or Metastatic Breast Cancer
    hormonal receptor
    HR positive
    Anti-TROP2
    Human epidermal growth factor receptor 2 (HER2) Negative
    Antibody Drug Conjugate
    Additional relevant MeSH terms:
    Breast Neoplasms
    Gemcitabine
    Capecitabine
    Vinorelbine

    Study Results

    No Results Posted as of Apr 21, 2022