What is sacituzumab govitecan studying for triple-negative breast cancer?

Sacituzumab govitecan is being studied to see if it can improve treatment outcomes for patients with lower-risk, early-stage triple-negative breast cancer. Researchers are comparing sacituzumab govitecan alone versus in combination with pembrolizumab to evaluate their effectiveness and safety. The study is sponsored by the West German Study Group to address important treatment questions for this patient group.

Who may be eligible for this triple-negative breast cancer clinical trial?

Women aged 18 years or older with triple-negative breast cancer that is estrogen and progesterone receptor negative or low positive and HER2 negative may be eligible. Patients must have early-stage disease without distant metastases and meet specific health and laboratory requirements. This trial is for female patients only. Please review eligibility criteria for more details.

Is there any cost to participate in this triple-negative breast cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses or other costs related to participation may vary and are not guaranteed to be covered. Participants should plan accordingly for any expenses related to travel or lodging.

Actively Recruiting

Phase 3

Age: 18Years +

FEMALE

ID06081244

NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Sacituzumab Govitecan Versus Sacituzumab GovitecanPembrolizumab in Low-risk, Triple-negative Early Breast Cancer ADAPT-TN-III

Led by West German Study Group · Updated on 2025-11-19

348

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating treatments for triple-negative breast cancer TNBC, a type of breast cancer known for its aggressive nature, poor outlook, and diverse molecular features. The study focuses on patients with lower-risk, early-stage TNBC, where current chemotherapy standards exist but optimal treatment strategies and durations remain unclear. This trial aims to compare neoadjuvant therapies to improve outcomes in this common patient group, addressing a significant medical need in Western Europe and the USA. The trial compares two neoadjuvant treatment options sacituzumab govitecan SG alone versus SG combined with pembrolizumab PEM. Both treatments are given intravenously over 12 weeks in four cycles. Depending on the patients response after 12 weeks, some may receive additional cycles before surgery. After surgery, further treatment depends on the pathological response, with some patients receiving chemotherapy if residual cancer remains. The study evaluates if these regimens can achieve high rates of complete remission with a better safety profile compared to standard chemotherapy. Participants will undergo regular clinical assessments, including pathology reviews and imaging, throughout treatment and follow-up. Researchers will monitor responses at surgery, invasive disease-free survival up to three years, and overall survival over six years. Quality of life is also assessed through questionnaires during and after treatment. The trial involves careful safety monitoring and long-term follow-up to understand the effects of these therapies on disease recurrence and patient well-being.

CONDITIONS

Brief Title

NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)

Who Can Participate

Age: 18Years +

FEMALE

Eligibility Criteria

You may qualify if you...

Female patients aged 18 years or older
Diagnosed with estrogen receptor (ER) and progesterone receptor (PR) negative or low positive (\u226410% positive cells in IHC), and HER2 negative breast cancer
Histologically confirmed unilateral, primary invasive breast carcinoma
Clinical stage I (cT1a-c, cN0) or stage II only if not qualifying for polychemotherapy plus pembrolizumab
No clinical evidence of distant metastasis (M0)
Tumor block available for central pathology review
ECOG performance status \u2264 1 or Karnofsky Index \u2265 80%
Negative pregnancy test within 7 days before registration for premenopausal patients
Willing and able to comply with study requirements and follow-up
Laboratory requirements met for blood counts and organ function
Post-menopausal status defined by specific criteria or use of contraception if applicable
Agreement to use effective contraception for female patients of childbearing potential and male participants
Provided written informed consent

You will not qualify if you...

Known hypersensitivity to study drugs or their components
Prior malignancy with less than 5 years disease-free survival, except certain skin or cervical cancers
History of invasive breast cancer
Previous or current cytotoxic treatment for non-cancer reasons unless approved
Concurrent treatment with other experimental drugs
Participation in another interventional trial within 30 days before entry
Pregnancy or breastfeeding
Conditions indicating poor compliance or inability to consent
Known polyneuropathy grade 2 or higher
Severe co-morbidities affecting treatment safety
Uncontrolled infections requiring intravenous treatment
History of pneumonitis
Active immunodeficiency, HIV infection, or active hepatitis B or C infection
Positive tests for hepatitis B surface antigen, hepatitis C RNA, or HIV antibody

Research Team

Oleg Gluz, PD Dr.

Anja Braschoß

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