NCT04647916|Active Not RecruitingPhase 2DMCFDA Drug

Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases

A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients With HER2-Negative Breast Cancer and Brain Metastases

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

S2007NCI-2020-07706U10CA180888

Study Type

interventional

Target

Locations

1 country

Sites

296

Timeline

RegisteredDec 2020

StartedJun 2021

CompletionDec 2028

Brief Summary

This phase II trial studies the effect of sacituzumab govitecan in treating patients with HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as Trop-2 receptors, and delivers govitecan to kill them. Giving sacituzumab govitecan may shrink the cancer in the brain and/or extend the time until the cancer gets worse.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

31mo left

Started Jun 2021

Longer than P75 for phase_2

Geographic Reach

1 country

296 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.5 years study duration

Study Progress66%

Jun 2021Dec 2028

First Submitted

Initial submission to the registry

November 23, 2020

Completed

8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed

6 months until next milestone

Study Start

First participant enrolled

June 8, 2021

Completed

6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

6.6 years

First QC Date

November 23, 2020

Last Update Submit

May 4, 2026

Conditions

Anatomic Stage IV Breast Cancer AJCC v8 Invasive Breast Carcinoma Metastatic HER2 Negative Breast Carcinoma Metastatic Malignant Neoplasm in the Brain Prognostic Stage IV Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

Objective response rate (ORR)
ORR will be evaluated using use a Simon two-stage minimax design.
Up to 2 years

Secondary Outcomes (3)

Overall survival
From date of registration to date of death due to any cause, assessed up to 2 years
Progression-free survival
From date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 2 years
Incidence of adverse events
Up to 2 years

Study Arms (1)

Treatment (sacituzumab govitecan)

EXPERIMENTAL

Patients receive sacituzumab govitecan IV over 1-3 hours on days 1 and 8. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Biological: Sacituzumab Govitecan

Interventions

Sacituzumab GovitecanBIOLOGICAL

Given IV

Also known as: hRS7-SN38 Antibody Drug Conjugate, IMMU-132, RS7-SN38, Sacituzumab Govitecan-hziy, Trodelvy

Treatment (sacituzumab govitecan)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants must have histologically confirmed HER2-negative (per 2018 American Society of Clinical Oncology \[ASCO\]/College of American Pathologists \[CAP\] joint guideline) invasive breast cancer that has metastasized to the brain. NOTE: Pathology report must confirm HER2-negative invasive breast cancer. Brain metastases must be confirmed by radiology report
Participants must have an magnetic resonance imaging (MRI) of the brain within 28 days prior to registration and must have central nervous system metastases with at least one measurable brain metastasis \>= 1.0 cm in size (per RANO-BM) that has not been irradiated, or has progressed despite prior radiation therapy (in the opinion of the treating physician). In the rare case that a previously irradiated brain metastasis is the sole target lesion and if there is concern about possible radiation necrosis, patient is eligible only if there is clear progression in the previously radiated lesion. Computed tomography (CT) of the head cannot substitute for brain MRI. All central nervous system (CNS) disease must be assessed and documented on the S2007 Brain Metastases Baseline Tumor Assessment Form
Participants may have measurable or non-measurable extracranial disease. All measurable disease must be assessed within 28 days prior to registration; all non-measurable disease must be assessed within 42 days prior to registration. Participants are NOT required to have extracranial disease, but must have scans done to document disease status at baseline. All extracranial disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1). NOTE: Brain lesions should not be included on the Baseline Tumor Assessment Form (RECIST 1.1) for this study
Participants must have had CNS progression after previous CNS-directed therapy (radiation therapy, surgery, or any combination of therapy)
Participants must have resolution of adverse event(s) of the most recent prior systemic anti-cancer therapy to \< grade 2, with the exception of alopecia and =\< grade 2 neuropathy, which are allowed
Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Participants must have Zubrod performance status 0 or 1
Participants must have history and physical exam obtained within 21 days prior to registration
Absolute neutrophil count (ANC) \>= 1,500/mcL (obtained within 21 days prior to registration)
Platelet count \>= 100,000/mcL (obtained within 21 days prior to registration)
Hemoglobin \>= 9.0 g/dL (obtained within 21 days prior to registration)
Total bilirubin =\< 1.5 times institutional upper limit of normal (ULN) (obtained within 21 days prior to registration)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x institutional ULN (obtained within 21 days prior to registration)
Participants must have a serum creatinine =\< 1.5 times the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance \>= 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 21 days prior to registration
Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification, and must be class 2B or better
+2 more criteria

You may not qualify if:

Participants must not have had more than 2 seizures within 28 days prior to registration
Participants must not have received systemic therapy (including small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (e.g., tamoxifen) within 7 days prior to registration
Participants must not have received anti-cancer biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to registration
Participants must not have received nitrosoureas or mitomycin C within 42 days, metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days prior to registration
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral agents that are strong CYP3A4 inhibitors or inducers and who are unwilling or unable to change to antiretroviral therapies without such interactions are ineligible because of the potential for pharmacokinetic interactions with sacituzumab govitecan (IMMU-132)
Due to potential drug interactions of anti-retroviral drugs with sacituzumab govitecan (IMMU-132), participants must not have known active or chronic hepatitis B virus (HBV) infection, requiring suppressive therapy or known active hepatitis C virus (HCV) infection. Participants with a known history of HCV infection must have been treated and cured
Participants must not have received enzyme-inducing anti-epileptic agents (e.g., carbamazepine, phenytoin, phenobarbital, primidone) within 7 days prior to registration or within 14 days of planned start of cycle 1, day 1 treatment, and participants must not be planning to receive enzyme-inducing anti-epileptic agents (e.g., carbamazepine, phenytoin, phenobarbital, primidone) for the duration of protocol treatment
Participants must not be receiving warfarin (or other coumarin derivatives) at time of registration or be planning to receive warfarin (or other coumarin derivatives) for the duration of protocol treatment. Participants who are able to switch to low molecular weight heparin (LMWH) or direct oral anticoagulants (DOACs) prior to date of registration (and plan to remain off of warfarin or other coumarin derivatives) for the duration of protocol treatment) are eligible
Patients must not be receiving or be planning to receive concomitantly any other anti-cancer therapy, including endocrine therapy. Note: Concomitant hormone replacement therapy is allowed
Participants must not have a condition requiring ongoing systemic treatment with corticosteroids (\> 4 mg daily dexamethasone \[or bioequivalent\]) or other immunosuppressive medications within 7 days prior to the baseline MRI. Corticosteroids administration must be stable and planned to remain =\< 4 mg daily for the duration of protocol treatment. However, use of corticosteroids for clinical symptoms is allowed based upon treating physician discretion
Participants must not have uncontrolled diabetes in the opinion of the treating investigator 21 days prior to registration
Participants must not be pregnant or nursing. Women of reproductive potential must have a negative serum or urine pregnancy test within 7 days prior to registration. Women and men of reproductive potential must have agreed to use an effective contraceptive method for the duration of protocol treatment and for at least 6 months after the last dose of sacituzumab govitecan (IMMU-132). A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined, he/she is responsible for beginning contraceptive measures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

SWOG Cancer Research Networklead
Gilead Sciencescollaborator
National Cancer Institute (NCI)collaborator

Study Sites (296)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC