20 Participants Needed

Sacituzumab Govitecan for Breast Cancer

SC
Overseen ByStephen Chia, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: British Columbia Cancer Agency
Must be taking: CDK4/6 inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment option called sacituzumab govitecan (an antibody-drug conjugate) for individuals with advanced breast cancer that is hormone-sensitive and HER2-negative. The aim is to determine if this treatment can benefit patients whose cancer has progressed despite previous therapies, such as CDK4/6 inhibitors and trastuzumab deruxtecan. Researchers seek to understand the effectiveness of sacituzumab govitecan when used after trastuzumab deruxtecan. Suitable candidates have breast cancer deemed incurable by surgery but have received specific prior therapies, including chemotherapy and trastuzumab deruxtecan. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients with stable doses of anticonvulsants and corticosteroids can participate, suggesting some medications may be allowed.

Is there any evidence suggesting that sacituzumab govitecan is likely to be safe for humans?

Previous studies have shown that sacituzumab govitecan (SG) is generally well-tolerated by breast cancer patients. Research indicates that SG's safety profile aligns with earlier findings, revealing no new safety concerns. A detailed review and analysis demonstrated that SG is effective and tolerable, with only minor side effects reported. While some side effects may occur, they are usually manageable. Overall, SG has been used safely in other cancer patients, supporting its use in ongoing research.12345

Why do researchers think this study treatment might be promising for breast cancer?

Sacituzumab Govitecan is unique because it combines an antibody with a cancer-killing drug, specifically targeting the Trop-2 protein found on many breast cancer cells. This targeted approach allows for more precise delivery of the chemotherapy directly to the cancer cells, potentially reducing damage to healthy cells and minimizing side effects. Researchers are excited about this treatment because it offers a novel mechanism of action compared to conventional chemotherapy, which typically affects both cancerous and healthy cells indiscriminately. Additionally, Sacituzumab Govitecan has shown promise in patients who have not responded to other treatments, providing hope for those with limited options.

What evidence suggests that sacituzumab govitecan might be an effective treatment for breast cancer?

Studies have shown that sacituzumab govitecan effectively treats certain types of breast cancer. This treatment targets Trop-2, a protein often found in high amounts on cancer cells, and delivers a potent drug that halts cancer cell growth. Research indicates that sacituzumab govitecan can help patients live longer without disease progression and can also increase overall survival in patients with HR+/HER2- breast cancer. In some studies, patients treated with this drug achieved better results compared to other treatments. Although there is interest in using sacituzumab govitecan after trastuzumab deruxtecan, more specific evidence is needed for this sequence. Participants in this trial will receive sacituzumab govitecan as the investigational treatment.15678

Are You a Good Fit for This Trial?

This trial is for individuals with advanced hormone-positive, HER2-negative metastatic breast cancer who have already undergone treatment with CDK4/6 inhibitors and endocrine therapy. Participants will be selected based on their genetic makeup from tumor biopsies to find those likely to respond to the study drug.

Inclusion Criteria

Willing and able to provide signed informed consent approved by UBC/BC Cancer REB
My breast cancer is ER+ and HER2 low, and it has spread.
My tumor can be safely biopsied for genetic testing.
See 8 more

Exclusion Criteria

Pregnancy and breast feeding
My tumor cannot be safely biopsied.
I am not open to considering treatments that affect my whole body.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Biopsy and Sequencing

Tumor specimens are collected from biopsies, and whole genome and transcriptome sequencing is performed

3 weeks
1 visit (in-person)

Treatment

Patients receive sacituzumab govitecan (SG) at an initial dose of 10 mg per kilogram intravenously on day 1 and 8 of 21 day cycles

Until disease progression or significant toxicity
Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 12 months
Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Sacituzumab Govitecan
Trial Overview The trial tests Sacituzumab Govitecan (SG) in patients after they've progressed following Trastuzumab Deruxtecan (T-DXd) treatment. It aims to understand if SG can be effective when used sequentially and identify genomic markers predicting response.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Sacituzumab GovitecanExperimental Treatment1 Intervention

Sacituzumab Govitecan is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Trodelvy for:
🇪🇺
Approved in European Union as Trodelvy for:
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Approved in Canada as Trodelvy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials
181
Recruited
95,900+

Gilead Sciences

Industry Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Published Research Related to This Trial

Sacituzumab govitecan-hziy (TRODELVY) received accelerated FDA approval for treating metastatic triple-negative breast cancer (mTNBC) based on a trial involving 108 patients, showing an objective response rate of 33.3% and a median duration of response of 7.7 months.
The safety profile was assessed in a larger group of 408 patients, with common side effects including nausea, neutropenia, and fatigue, occurring in 25% or more of patients, indicating that while effective, the treatment can have significant adverse reactions.
FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer.Wahby, S., Fashoyin-Aje, L., Osgood, CL., et al.[2022]
Sacituzumab govitecan (SG) significantly improved progression-free survival (PFS) in patients with endocrine-resistant HR+/HER2- metastatic breast cancer, showing a 34% reduction in the risk of progression or death compared to standard chemotherapy.
The safety profile of SG was manageable, with notable grade ≥ 3 adverse events including neutropenia and diarrhea, but it still represents a promising treatment option for patients with limited alternatives.
Sacituzumab Govitecan in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer.Rugo, HS., Bardia, A., Marmé, F., et al.[2023]
Sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2, showed promising therapeutic activity in a phase I trial with 25 patients suffering from various metastatic solid cancers, achieving partial responses in two patients and stable disease in 16 others.
The maximum tolerated dose was determined to be 12 mg/kg for the first cycle, with lower doses (8 and 10 mg/kg) being safer for extended treatment, leading to acceptable toxicity levels and disease control for up to 36 weeks.
First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors.Starodub, AN., Ocean, AJ., Shah, MA., et al.[2022]

Citations

Gilead Provides Update on Phase 3 ASCENT 07 StudyThe ASCENT-07 study is a global, open-label, randomized Phase 3 trial evaluating the efficacy and safety of Trodelvy (sacituzumab govitecan-hziy) ...
Patient-Reported Outcomes (PROs)TRODELVY (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients
NCT03901339 | Study of Sacituzumab Govitecan-hziy ...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)
Effectiveness of sacituzumab govitecan and management ...We describe the real-world effectiveness of SG as 2L+ mTNBC treatment and the proportion of patients with neutropenia and its management.
Trodelvy® (sacituzumab govitecan-hziy) Efficacy and ...SG is indicated for the treatment of adult patients with unresectable locally advanced or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who ...
Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults ...The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day ...
Efficacy and safety of sacituzumab govitecan Trop-2- ...Our systematic review and meta-analysis confirmed that SG confers good clinical activity in certain solid tumor types and was tolerable with minimal adverse ...
Safety profile of sacituzumab govitecan in patients with ...This systematic review and meta-analysis provides extensive data on the safety and management of SG toxicity in BC patients across clinical trials.
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