Sacituzumab Govitecan for Triple-Negative Breast Cancer

(ASCENT-03 Trial)

Not currently recruiting at 440 trial locations

Overseen By Gilead Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Gilead Sciences

Must not be taking: Topoisomerase inhibitors

Disqualifiers: Pregnancy, Active infection, Second malignancy, 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, ongoing 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 called sacituzumab govitecan-hziy for individuals with advanced or metastatic triple-negative breast cancer that cannot be surgically removed. The study aims to determine if this treatment can better prevent cancer progression compared to standard treatments. It seeks participants with this type of breast cancer who either lack the PD-L1 protein in their tumors or have previously received certain treatments if their tumors do have this protein. Participants must have cancer measurable by scans like CT or MRI. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to help potentially bring a new treatment to market.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic anticancer treatment, you must have completed it at least 6 months before joining the trial.

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

Research has shown that sacituzumab govitecan is generally well-tolerated by patients with breast cancer. Studies have found that this treatment maintains a consistent safety record. Common side effects include low white blood cell counts and diarrhea, which can be managed with proper care.

The ASCENT trial focused on sacituzumab govitecan for patients with triple-negative breast cancer. It confirmed the treatment's safety and demonstrated that patients lived longer without their cancer worsening compared to those on standard chemotherapy.

Overall, sacituzumab govitecan has undergone extensive study and has a predictable safety profile, making it a viable option for patients considering this treatment in a clinical trial. ^{1 2 3 4 5}

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

Sacituzumab Govitecan-hziy is unique because it combines an antibody with a chemotherapy drug, creating a powerful targeted treatment for triple-negative breast cancer. This approach targets a protein called Trop-2, which is often overexpressed in these cancer cells, allowing for direct delivery of the chemotherapy to the cancer while sparing more healthy tissue. Unlike traditional chemotherapy options like paclitaxel or gemcitabine, which affect both cancerous and healthy cells, Sacituzumab Govitecan-hziy offers a more focused attack on the cancer, potentially leading to fewer side effects and improved outcomes. Researchers are excited about this treatment because it represents a more precise and potentially more effective therapy option for a challenging form of breast cancer.

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

Research has shown that sacituzumab govitecan (SG), which participants in this trial may receive, effectively treats metastatic triple-negative breast cancer (mTNBC). One study found that SG outperformed standard chemotherapy for patients unable to use immune checkpoint inhibitors. In real-world situations, patients treated with SG experienced significant benefits, living longer without disease progression and having an overall longer survival. SG is already approved for treating mTNBC, underscoring its effectiveness in managing this challenging cancer type. Meanwhile, another group of participants in this trial will receive a treatment of the physician's choice, which includes options like paclitaxel, nab-paclitaxel, or gemcitabine with carboplatin. ^{1 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 previously untreated advanced or metastatic triple-negative breast cancer that doesn't show PD-L1, or those who've had anti-PD-(L)1 treatment if their tumors are PD-L1 positive. Participants must have good organ function, not be pregnant, and agree to use contraception. They can't join if they've had recent cancer treatments, active infections requiring antibiotics, another active cancer, or haven’t recovered from past treatment side effects.

Inclusion Criteria

My breast cancer was already at an advanced stage when first diagnosed.

I have triple-negative breast cancer that has not been treated and cannot be removed by surgery.

I agree to use birth control as required by the study.

Exclusion Criteria

Positive serum pregnancy test or women who are lactating

May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible

I am HIV positive and have had Kaposi sarcoma or Multicentric Castleman Disease.

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 or Treatment of Physician's Choice in cycles

21-28 days per cycle, ongoing 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 57 months

What Are the Treatments Tested in This Trial?

Interventions

• Sacituzumab Govitecan-hziy

Trial Overview The study compares Sacituzumab Govitecan-hziy (SG), a new drug for breast cancer, against the physician's choice of standard treatments like Paclitaxel or nab-Paclitaxel combined with Gemcitabine and Carboplatin. The main goal is to see which option keeps the cancer from worsening longer (progression-free survival).

How Is the Trial Designed?

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

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

Group II: Treatment of Physician's Choice (TPC) Active Control 4 Interventions

Participants will receive TPC determined prior to randomization from 1 of the 3 allowed regimens: * Paclitaxel 90 mg/m\^2 on Days 1, 8, and 15 of a 28-day cycle * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of a 28-day cycle * Gemcitabine 1000 mg/m\^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 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

In a study of 43 patients with metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan, the median overall survival was 13.1 months, indicating its effectiveness in a real-world setting.

Common adverse events included alopecia, diarrhea, and neutropenia, with 27.9% of patients experiencing Grade 3 neutropenia, highlighting the need for careful management of side effects during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of sacituzumab govitecan in patients with metastatic triple-negative breast cancer in real-world settings: first observations from an interdisciplinary breast cancer centre in Germany. Reinisch, M., Bruzas, S., Spoenlein, J., 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 (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 received full FDA approval after a phase III trial showed it significantly improves progression-free survival in patients with metastatic triple-negative breast cancer, achieving a median of 5.7 months compared to just 1.7 months with standard chemotherapy.

This treatment is an antibody-drug conjugate that targets the Trop-2 receptor and delivers the active metabolite of irinotecan, SN-38, directly to cancer cells, making it a promising option for patients who have already undergone at least two prior therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan for Treatment of Refractory Triple-Negative Metastatic Breast Cancer. Fleming, PJ., Karpio, S., Lombardo, N.[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 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 3 trial involving 468 patients with metastatic triple-negative breast cancer, sacituzumab govitecan significantly improved progression-free survival (5.6 months) and overall survival (12.1 months) compared to standard chemotherapy (1.7 months and 6.7 months, respectively).

While sacituzumab govitecan showed better efficacy, it was associated with higher rates of certain adverse events, such as neutropenia (51% vs. 33% with chemotherapy) and diarrhea (10% vs. <1%), but no deaths were linked to the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. Bardia, A., Hurvitz, SA., Tolaney, SM., et al.[2022]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2511734

Sacituzumab Govitecan in Untreated, Advanced Triple- ... Here, we report the primary results from the ASCENT-03 trial of sacituzumab govitecan as compared with chemotherapy for the first-line treatment ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39353151/

Real-World Clinical Outcomes With Sacituzumab Govitecan in ... Sacituzumab govitecan (SG) is approved for the treatment of metastatic triple-negative breast cancer (mTNBC). We report the real-world clinical effectiveness ...

3. dana-farber.org dana-farber.org/newsroom/news-releases/2025/adc-improves-outcomes-for-patients-with-advanced-triple-negative-breast-cancer-who-are-ineligible-for-immune-checkpoint-inhibitors

ADC Improves Outcomes for Patients with Advanced Triple ... "The data from ASCENT-03 are very compelling and support sacituzumab govitecan as a potential new standard of care for patients with previously ...

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

Real-World Clinical Outcomes With Sacituzumab ... Sacituzumab govitecan (SG) is approved for the treatment of metastatic triple-negative breast cancer (mTNBC). We report the real-world clinical effectiveness ...

6. trodelvyhcp.com trodelvyhcp.com/mtnbc/safety/safety

TRODELVY® (sacituzumab govitecan-hziy) Safety Profile Safety analyses from the phase 3 ASCENT trial of sacituzumab govitecan in metastatic triple-negative breast cancer. NPJ Breast Cancer. 2022;8(1):98. 2. TRODELVY ...

7. gilead.com gilead.com/news/news-details/2025/ascent-03-trodelvy-demonstrates-highly-statistically-significant--clinically-meaningful-improvement-in-progression-free-survival-in-patients-with-first-line-metastatic-triple-negative-breast

ASCENT 03 Trodelvy Demonstrates Highly Statistically ... The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39263951/

Sacituzumab-govitecan in metastatic triple-negative breast ... Results: Sgov effectiveness data seem to be slightly inferior than expected. Furthermore, it is observed that patients with an Eastern ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11648803/

Safety profile of sacituzumab govitecan in patients with breast ... This systematic review and meta-analysis provides extensive data on the safety and management of SG toxicity in BC patients across clinical trials.