NCT04595565: SASCIA

Sacituzumab Govitecan in Primary HER2-negative Breast Cancer

Active, enrolled Phase 3 Last updated 25 November 2025

What this trial tests

Phase 3 trial testing Capecitabine in HER2-negative Breast Cancer in 1,332 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

28 October 2020

Primary endpoint
30 March 2027

30 March 2029

Quick facts

Lead sponsor	GBG Forschungs GmbH
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,332
Start date	28 October 2020
Primary completion	30 March 2027
Estimated completion	30 March 2029
Sites	163 locations across France, Belgium, Austria, Ireland, Germany, Switzerland, Spain

Drugs / interventions tested

• Capecitabine (capecitabine) — full drug profile →
• Carboplatin (Carboplatin) — full drug profile →
• Cisplatin (cisplatin) — full drug profile →
• Sacituzumab govitecan — full drug profile →

Conditions studied

• HER2-negative Breast Cancer — all drugs for HER2-negative Breast Cancer →
• Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →

Sponsor

GBG Forschungs GmbH — full company profile →

Who can join

Adults 18 to 99, any sex, with HER2-negative Breast Cancer or Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to:

* Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles);
* Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation.

Treatment in either arm will be given for eight cycles.

In patients with HR-positive breast cancer, endocrine-based therapy, which includes the use of CDK4/6 inhibitors, will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents.

Adjuvant pembrolizumab can be given until the completion of radiotherapy before randomization. Within the study the use of pembrolizumab in patients with TNBC who received pembrolizumab as neoadjuvant therapy is allowed as monotherapy in the TPC arm, according to the approval of pembrolizumab in this setting.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent advances in therapeutic strategies for triple-negative breast cancer.
   Li Y, Zhang H, Merkher Y, Chen L, et al · · 2022 · cited 643× · PMID 36038913 · DOI 10.1186/s13045-022-01341-0
2. Triple negative breast cancer: Pitfalls and progress.
   Zagami P, Carey LA. · · 2022 · cited 546× · PMID 35987766 · DOI 10.1038/s41523-022-00468-0
3. Emerging new therapeutic antibody derivatives for cancer treatment.
   Jin S, Sun Y, Liang X, Gu X, et al · · 2022 · cited 304× · PMID 35132063 · DOI 10.1038/s41392-021-00868-x
4. Antibody-drug conjugates targeting TROP-2: Clinical development in metastatic breast cancer.
   Shastry M, Jacob S, Rugo HS, Hamilton E. · · 2022 · cited 104× · PMID 36302269 · DOI 10.1016/j.breast.2022.10.007
5. Resistance to antibody-drug conjugates in breast cancer: mechanisms and solutions.
   Chen YF, Xu YY, Shao ZM, Yu KD. · · 2023 · cited 93× · PMID 36357174 · DOI 10.1002/cac2.12387
6. Therapeutic progress and challenges for triple negative breast cancer: targeted therapy and immunotherapy.
   Yang R, Li Y, Wang H, Qin T, et al · · 2022 · cited 86× · PMID 35243562 · DOI 10.1186/s43556-022-00071-6
7. Current Treatment Landscape for Early Triple-Negative Breast Cancer (TNBC).
   Lee J. · · 2023 · cited 83× · PMID 36836059 · DOI 10.3390/jcm12041524
8. Trop-2 as a Therapeutic Target in Breast Cancer.
   Sakach E, Sacks R, Kalinsky K. · · 2022 · cited 64× · PMID 36497418 · DOI 10.3390/cancers14235936