Sacituzumab Govitecan for Breast Cancer

(ASCENT-07 Trial)

Not currently recruiting at 347 trial locations

Overseen By Gilead Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Gilead Sciences

Must be taking: Antiretroviral therapy

Must not be taking: Investigational drugs, Topoisomerase I inhibitors

Disqualifiers: Active second malignancy, Serious infection, Hepatitis B/C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 21-28 days per cycle, repeated until progression or unacceptable toxicity

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, sacituzumab govitecan-hziy, to determine if it helps people with HR+/HER2- metastatic breast cancer live longer and prevent cancer growth compared to treatments like paclitaxel, nab-paclitaxel, or capecitabine. It targets those whose cancer has worsened despite at least two previous hormone treatments. Individuals with HR+/HER2- metastatic breast cancer who have not found success with other treatments might be suitable candidates for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering access to a potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot be enrolled in another clinical study or use investigational drugs close to the trial start date.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that sacituzumab govitecan is generally well-tolerated by patients. Studies have found that the most common side effects include low white blood cell count, nausea, diarrhea, low red blood cell count, and tiredness. More serious side effects, such as fever with low white blood cell count, occurred less frequently. In some studies, patients with breast cancer experienced these side effects but continued treatment, indicating they were manageable for most.

Sacituzumab govitecan is already approved for another type of breast cancer, so its safety is well understood. This approval also means doctors have extensive experience managing its side effects. Prospective trial participants should discuss any concerns with their doctor to understand what these side effects could mean for them. ^{1 2 3 4 5}

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

Sacituzumab Govitecan-hziy is unique because it combines an antibody with a chemotherapy agent, specifically targeting cancer cells in breast cancer. This drug works by delivering a toxic payload directly to the tumor, sparing more healthy cells compared to traditional chemotherapy. Researchers are excited about this treatment because it offers a targeted approach, potentially reducing side effects and improving effectiveness for patients who have limited options. Unlike standard therapies such as paclitaxel or capecitabine, which broadly attack rapidly dividing cells, Sacituzumab Govitecan-hziy precisely homes in on cancer cells, offering a new hope for those battling this condition.

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

Research shows that sacituzumab govitecan, which participants in this trial may receive, can help treat certain types of breast cancer. Earlier studies found that this medication reduced the risk of cancer progression or death by 38% compared to standard chemotherapy for patients with metastatic triple-negative breast cancer. This suggests it might slow the cancer's growth or spread more effectively than some other treatments. In one study, patients who received sacituzumab govitecan lived an average of 12.1 months, significantly longer than the 6.7 months for those on other treatments. These results suggest that sacituzumab govitecan may offer hope for people facing hard-to-treat breast cancer. Meanwhile, participants in the trial may also receive a treatment of the physician's choice, including options like paclitaxel, nab-paclitaxel, or capecitabine. ^{3 6 7 8 9}

Who Is on the Research Team?

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

This trial is for adults with HR+/HER2- metastatic breast cancer who've had disease progression despite endocrine therapy. They must have a sample of tumor tissue available, not be candidates for further endocrine treatment, and have adequate organ function. HIV-positive participants need controlled infection on ART. Participants must agree to use contraception and should not be eligible for curative intent therapy or have received certain prior treatments.

Inclusion Criteria

My breast cancer is hormone receptor positive and has spread, confirmed by a recent biopsy.

My organs are functioning well.

My cancer returned within 24 months while on hormone therapy, counting as one treatment line.

Exclusion Criteria

I haven't taken any experimental estrogen-blocking drugs in the last 14 days.

I am HIV positive with a history of Kaposi sarcoma or Multicentric Castleman Disease.

My breast cancer is advanced but considered treatable with the intent to cure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either sacituzumab govitecan-hziy (SG) or treatment of physician's choice (TPC) based on randomization

21-28 days per cycle, repeated until progression or unacceptable toxicity

Visits on Days 1, 8, and 15 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 60 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Capecitabine
• Nab-paclitaxel
• Paclitaxel
• Sacituzumab Govitecan-hziy

Trial Overview The study tests if Sacituzumab Govitecan (SG) extends the time without cancer growth in patients with HR+/HER2- metastatic breast cancer compared to standard treatments like Paclitaxel, Nab-paclitaxel, or Capecitabine. It measures how long patients live without their disease getting worse.

How Is the Trial Designed?

Group I: Sacituzumab Govitecan-hziy (SG) Experimental Treatment 1 Intervention

Participants will receive SG at a dose of 10 mg/kg infusion on Days 1 and 8 of a 21-day cycle.

Group II: Treatment of Physician's Choice (TPC) Active Control 3 Interventions

Participants will receive TPC determined prior to randomization to 1 of the 3 allowed regimens: * paclitaxel 80 mg/m\^2 over 1 hour (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. * nab-Paclitaxel 100 mg/m\^2 over 30 minutes (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. * capecitabine at 1000-1250 mg/m\^2 twice daily for 2 weeks followed by a 1-week rest period of a 21-day cycle.

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

Approved in United States as Trodelvy for:

• Metastatic triple-negative breast cancer
• Metastatic urothelial cancer
• Metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer

Approved in European Union as Trodelvy for:

• Metastatic triple-negative breast cancer

Approved in Canada as Trodelvy for:

• Metastatic triple-negative breast cancer

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

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 (IMMU-132) has been shown to prolong progression-free survival in patients with advanced triple-negative breast cancer, indicating its efficacy as a treatment option.

The treatment is well tolerated, resulting in fewer and more manageable side effects compared to traditional irinotecan, suggesting a safer profile for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An ADC for Triple-Negative Breast Cancer. [2018]

Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2 and delivers a topoisomerase I inhibitor, showing promise in treating metastatic triple-negative breast cancer (mTNBC) after at least two prior therapies.

In April 2020, it received accelerated approval in the USA for mTNBC, and it is currently undergoing further clinical trials for various cancers, indicating its potential as a versatile treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan: First Approval. Syed, YY.[2021]

Sacituzumab govitecan (SG) demonstrated effectiveness in treating relapsed or refractory metastatic triple-negative breast cancer (RM-TNBC), with a median overall survival of 12.9 months and an objective response rate of 34% based on an analysis of 412 patients across three trials.

The treatment was associated with significant adverse effects, particularly myelosuppression, with 46% of patients experiencing grade ≥3 neutropenia, and there were four treatment-related deaths reported, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrated analysis of Sacituzumab govitecan in relapsed or refractory metastatic triple-negative breast cancer. Cheng, SX., Chen, QC., Lin, GH., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 is an antibody-drug conjugate that targets Trop-2 and has shown a 33.3% overall response rate in patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies, based on a phase I/II study with 108 participants.

The treatment has a median duration of response of 7.7 months, and while it is generally well-tolerated, common side effects include nausea, neutropenia, and fatigue, indicating a need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. Seligson, JM., Patron, AM., Berger, MJ., et al.[2021]

In a phase 1/2 trial involving 108 patients with heavily pretreated metastatic triple-negative breast cancer, sacituzumab govitecan-hziy demonstrated a response rate of 33.3%, with a median duration of response of 7.7 months, indicating its efficacy in this challenging patient population.

The treatment was associated with significant myelotoxic effects, including anemia and neutropenia, but overall survival was promising at a median of 13.0 months, highlighting the need for careful monitoring of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. Bardia, A., Mayer, IA., Vahdat, LT., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11452463/

Real-world use patterns, effectiveness, and tolerability of ... Sacituzumab govitecan (SG), a Trop-2–directed antibody–drug conjugate, is approved for patients with mTNBC who have received ≥ 2 systemic therapies.

2. gilead.com gilead.com/news/news-details/2025/trodelvy-reduces-risk-of-disease-progression-or-death-by-38-versus-chemotherapy-as-first-line-therapy-in-patients-with-metastatic-triple-negative-breast-cancer-in-ascent-03-study

Trodelvy Reduces Risk of Disease Progression or Death ... Trodelvy® Reduces Risk of Disease Progression or Death by 38% Versus Chemotherapy as First-Line Therapy in Patients With Metastatic Triple-Negative Breast ...

3. ascopubs.org ascopubs.org/doi/10.1200/OP.24.00242

Real-World Clinical Outcomes With Sacituzumab ... We report the real-world clinical effectiveness and toxicity data of SG in patients with mTNBC.

4. esmoopen.com esmoopen.com/article/S2059-7029(25)01177-9/fulltext

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.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2028485

Sacituzumab Govitecan in Metastatic Triple-Negative ... The median overall survival was 12.1 months (95% CI, 10.7 to 14.0) with sacituzumab govitecan and 6.7 months (95% CI, 5.8 to 7.7) with ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40361516/

The Clinical Outcomes and Safety of Sacituzumab ... This multicenter, retrospective study aimed to evaluate real-world observational data describing the clinical outcomes, safety, and prognostic ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S096097762400184X

Safety profile of sacituzumab govitecan in patients with ... The outcomes of interest were absolute risk (AR) of all-grade and grade ≥3 TRAEs: neutropenia; nausea; diarrhea; anemia; febrile neutropenia; alopecia; fatigue; ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41007623/

Effectiveness and Safety of Sacituzumab Govitecan in Real ... Results: A total of 56 patients were included in this study (33 with mTNBC and 23 with HR+/HER2- mBC). In the mTNBC group, mPFS was 4.0 months ( ...

9. onclive.com onclive.com/view/sacituzumab-govitecan-upholds-efficacy-and-safety-in-real-world-mtnbc-population

Sacituzumab Govitecan Upholds Efficacy and Safety in ... Sacituzumab govitecan demonstrated consistent efficacy and safety in real-world mTNBC patients, with median OS of 11.3 months and PFS of 5.0 ...