CLINICAL TRIALS PROFILE FOR TRODELVY

Biosimilar Clinical Trials for TRODELVY

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06100874 ↗	A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)	Recruiting	Gilead Sciences	Phase 2	2023-11-20	This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer. The names of the study drugs used in this research study are: - Sacituzumab govitecan (a type of antibody-drug conjugate) - Trastuzumab (Herceptin) (a type of monoclonal antibody) - Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta) (a type of recombinant monoclonal antibody) - Trastuzumab biosimilar drug
NCT06100874 ↗	A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)	Recruiting	Adrienne G. Waks	Phase 2	2023-11-20	This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer. The names of the study drugs used in this research study are: - Sacituzumab govitecan (a type of antibody-drug conjugate) - Trastuzumab (Herceptin) (a type of monoclonal antibody) - Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta) (a type of recombinant monoclonal antibody) - Trastuzumab biosimilar drug

All Clinical Trials for TRODELVY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03971409 ↗	Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer	Recruiting	Array BioPharma	Phase 2	2019-07-08	This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab Govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as Tumor-associated calcium signal transducer 2 (TROP2) receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.
NCT03971409 ↗	Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer	Recruiting	Breast Cancer Research Foundation	Phase 2	2019-07-08	This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab Govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as Tumor-associated calcium signal transducer 2 (TROP2) receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.
NCT03971409 ↗	Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer	Recruiting	Hoosier Cancer Research Network	Phase 2	2019-07-08	This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab Govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as Tumor-associated calcium signal transducer 2 (TROP2) receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.
NCT03971409 ↗	Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Patients With Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer	Recruiting	Johns Hopkins University	Phase 2	2019-07-08	This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab Govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as Tumor-associated calcium signal transducer 2 (TROP2) receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.

Clinical Trial Conditions for TRODELVY

Condition Name

Condition Name for TRODELVY
Intervention	Trials
Triple Negative Breast Cancer	7
Breast Cancer	4
Metastatic Breast Cancer	4
HER2-negative Breast Cancer	3

Condition MeSH

Condition MeSH for TRODELVY
Intervention	Trials
Breast Neoplasms	15
Triple Negative Breast Neoplasms	8
Carcinoma	4
Urinary Bladder Neoplasms	3

Clinical Trial Locations for TRODELVY

Trials by Country

Trials by Country for TRODELVY
Location	Trials
United States	30
Germany	15
Spain	10
Australia	5
China	2

Trials by US State

Trials by US State for TRODELVY
Location	Trials
Massachusetts	7
Illinois	3
Ohio	2
Texas	2
Tennessee	2

Clinical Trial Progress for TRODELVY

Clinical Trial Phase

Clinical Trial Phase for TRODELVY
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
Phase 3	3

Clinical Trial Status

Clinical Trial Status for TRODELVY
Clinical Trial Phase	Trials
Recruiting	14
Not yet recruiting	10

Clinical Trial Sponsors for TRODELVY

Sponsor Name

Sponsor Name for TRODELVY
Sponsor	Trials
Gilead Sciences	14
Dana-Farber Cancer Institute	4
Immunomedics, Inc.	4

Sponsor Type

Sponsor Type for TRODELVY
Sponsor	Trials
Industry	32
Other	31
NIH	1

Last updated: April 26, 2026

TRODELVY (sacituzumab govitecan-hziy): Clinical Trials Update, Market Analysis, and Projection

What is TRODELVY and where does it sit in the development pipeline?

TRODELVY is an antibody-drug conjugate (ADC) that targets TROP2 and delivers SN-38 (a topoisomerase I inhibitor payload). It is marketed by Gilead (brand TRODELVY; generic sacituzumab govitecan-hziy).

Current key approved indications (commercial baseline)

• Metastatic triple-negative breast cancer (mTNBC) after at least two prior therapies (one of which may be for metastatic disease), per FDA approval history.
• Hormone receptor (HR)-positive, HER2-negative metastatic breast cancer after at least two prior endocrine-based regimens and at least two prior chemotherapy regimens for metastatic disease, with a requirement that the cancer is not responsive to hormonal therapy (per FDA label framework described in public summaries).
  Sources: FDA label information for TRODELVY and prescribing documentation [1], [2].

What is the latest clinical-trials direction across key tumor types?

A full, decision-grade “latest update” requires up-to-date trial registry snapshots and press-release-level timelines. The constraints here are that only high-confidence, citable information available in this working context can be used. With the information available, the update below focuses on established late-stage program themes and status framing that is routinely reflected in TRODELVY’s label-aligned development strategy: breast cancer expansion and sequencing studies, plus ongoing trials in other TROP2-expressing malignancies.

Program theme 1: Breast cancer expansion and sequencing

TRODELVY’s development strategy has consistently emphasized:

• earlier-line placement and combination regimens in breast cancer,
• refining patient selection based on biomarker and prior-therapy context,
• operationally leveraging TROP2 expression prevalence and ADC tolerability.

This theme is aligned with TRODELVY’s label basis in mTNBC and HR+/HER2- metastatic breast cancer, where the clinical evidence supports repeated use following prior chemotherapy and endocrine therapy exposure. [1], [2]

Program theme 2: Combination trials

ADC growth in oncology depends on:

• combining with immune checkpoint inhibitors, PARP inhibitors, or other systemic agents,
• maintaining manageable overlapping toxicity and consistent exposure.

TRODELVY’s trial ecosystem in publicly described programs reflects standard ADC combination approaches in TROP2-driven cancers, typically anchored by response rates, duration of response, and PFS endpoints in randomized or multi-arm designs. [1], [2]

What is the market opportunity: adoption drivers, competitive set, and pricing context?

Core demand drivers

1. Mechanism-based differentiation: TROP2 expression enables targeting beyond HR/HER2 status, supporting TRODELVY’s use across breast cancer subgroups when eligibility conditions are met. [1], [2]
2. Line-of-therapy traction: label-driven placement after prior systemic therapy reduces payer friction versus earlier-line products, while still capturing a large metastatic population. [1], [2]
3. Oncology ADC category growth: the ADC market has expanded on the strength of efficacy signals and a pipeline-wide move from “single-agent salvage” toward broader regimens. This supports continued uptake of label-conforming indications.

Competitive landscape (practical positioning)

TRODELVY competes in metastatic breast cancer with:

• chemotherapy options used post–standard endocrine/HER2 pathways,
• ADCs and targeted agents in overlapping salvage settings,
• checkpoint inhibitor combinations in eligible patients.

The competitive set varies by biomarker and prior-therapy history; TRODELVY’s clean differentiation is its ADC construct aimed at TROP2, with SN-38 as the cytotoxic payload. [1], [2]

Pricing and access

TRODELVY’s commercial trajectory is governed by:

• reimbursement coverage for metastatic, post-progression populations,
• prior authorization structures tied to label criteria,
• dose schedule and toxicity management (notably neutropenia and GI effects as reflected in prescribing information).

These operational factors shape realized net pricing and persistence. [1], [2]

How large is the addressable market, and how fast can it grow?

A decision-grade TAM/SAM/SOM model requires current incidence, stage distribution, treatment patterns, and payer constraints; none of that granular input can be produced reliably in this response without introducing uncited numeric assumptions. Under the constraints, the actionable projection below is built from label-relevant market mechanics (indication width, line of therapy, and adoption dynamics) rather than fabricated epidemiology.

Addressable market logic (label-relevant)

• mTNBC after multiple prior therapies is a concentrated, high-burden setting where ADC adoption has proven durable when response and tolerability are acceptable. [1], [2]
• HR+/HER2- metastatic breast cancer post endocrine and chemotherapy exposure expands the addressable pool beyond TNBC, tied to patient eligibility and sequencing norms. [1], [2]

Growth levers

• Indication expansion (if and when additional randomized or supportive evidence supports new label language).
• Combination penetration (if trial results translate into clinically and operationally usable regimens).
• Lifecycle optimization via safety management and patient selection.

These levers map directly to TRODELVY’s development strategy and label structure as reflected in prescribing documentation and FDA review materials. [1], [2]

Market projection: base case, upside, and risk scenarios

Because hard trial “latest readout” figures and current sales baselines are not fully citable in this context, the projection is expressed in scenario form tied to measurable, label-contingent events.

Base case (status-quo label + gradual conversion)

• TRODELVY sustains growth primarily through:
  • ongoing market conversion of eligible metastatic patients after prior lines,
  • incremental penetration in shared salvage categories within breast cancer,
  • regimen refinements that improve treatability.

Expected market behavior: steady-to-moderate growth driven by remaining addressable patients meeting label criteria. [1], [2]

Upside case (label expansion or strong combination readouts)

• Growth accelerates if:
  • trial results support broader line placement, earlier use, or additional breast cancer subtypes within eligibility,
  • combination trials translate into practice with manageable toxicity and clear benefit endpoints.

Expected market behavior: faster adoption and higher penetration because payers cover new cohorts where clinical evidence maps cleanly to label criteria. [1], [2]

Risk case (competing ADC diffusion or payer pushback)

• Growth slows if:
  • competing ADCs and targeted therapies compress TRODELVY’s share in overlapping segments,
  • safety and hospitalization rates increase total cost of care or trigger stricter utilization management,
  • comparative effectiveness evidence weakens relative positioning.

Expected market behavior: adoption becomes more conservative, with utilization limited to the most compelling biomarker and clinical subgroups. [1], [2]

What do the prescribing-data constraints imply for real-world uptake?

TRODELVY prescribing information frames:

• toxicity management requirements,
• contraindications/warnings that influence clinician confidence,
• dose modifications that affect schedule adherence.

These factors drive real-world effective dose intensity and persistence, which then feed realized demand versus trial efficacy. [1], [2]

Key decision indicators for investors and BD partners

Use the following metrics as “go/no-go” decision indicators tied to market outcomes:

• Label changes: new indications, line-of-therapy expansion, biomarker refinements (TROP2 status frameworks where applicable). [1], [2]
• Clinical endpoints in phase 3/registration-quality datasets: PFS and OS strength in randomized settings, and durability of response. [1], [2]
• Safety profile in combination use: rates of neutropenia, GI events, discontinuation, and need for supportive care that affects cost and adherence. [1], [2]
• Treatment sequencing evidence: how quickly TRODELVY is used post-progression and whether prior chemo or immunotherapy exposure shifts benefit-risk.

Key Takeaways

• TRODELVY is a TROP2-targeted ADC with label-based commercial reach focused on metastatic breast cancer after prior therapies, with uptake governed by label eligibility, toxicity management, and payer authorization structures. [1], [2]
• Market growth depends on breast cancer indication breadth, successful trial-to-label translation, and operationally tolerable combination strategies. [1], [2]
• Scenario projections hinge on measurable events: label expansions, randomized evidence quality for sequencing/combination use, and real-world safety and adherence metrics. [1], [2]

FAQs

1) Is TRODELVY an ADC and what is its payload?

Yes. TRODELVY (sacituzumab govitecan-hziy) is a TROP2-targeted antibody-drug conjugate delivering SN-38. [1], [2]

2) What cancer types does TRODELVY primarily target commercially?

Its label-supported commercial focus is metastatic breast cancer, including mTNBC and HR-positive, HER2-negative metastatic breast cancer after prior therapies. [1], [2]

3) What drives payer approval decisions for TRODELVY?

Payer decisions typically track label eligibility (line of therapy, prior treatment exposure) and safety/tolerability factors that determine utilization management. [1], [2]

4) What are the main risks to commercial performance?

Safety-related utilization friction (supportive care needs and dosing modifications), competitive ADC diffusion in salvage breast cancer, and any weakening of comparative benefit in new datasets. [1], [2]

5) What is the most important catalyst category for future growth?

New label support arising from registration-quality trials that expand eligible populations or improve sequencing/combination feasibility in metastatic breast cancer. [1], [2]

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). TRODELVY (sacituzumab govitecan-hziy) prescribing information / label. FDA.
[2] U.S. Food and Drug Administration. (n.d.). FDA label and approval-related materials for TRODELVY. FDA.