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

NCT06081244 | Recruiting Phase 3 DMC

• 1 other identifier: WSG-AM13 (ADAPT-TN-III)
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 42

Brief Summary

TNBC is known for poor prognosis, aggressive patterns of disease, and significant molecular heterogeneity. (Neo)adjuvant chemotherapy (NACT) is standard of care in all node-positive and in node-negative patients with a tumour size \>5 mm according to current National Comprehensive Cancer Network (NCCN) guidelines. However, TNBC patients with lower stage disease do clearly have a better prognosis compared to more advanced stages. Patients with stage I-II node-negative disease have 3-5 year iDFS rates of 80-90% (with majority of relapses within the first three years) as shown in several trials.Although survival results appear much better in the lower vs. higher stages, there is a high clinical need in this most common group of TNBC patients in Western Europe and USA.

Conditions

Triple Negative Breast Cancer

Keywords

TNBC; Early breast cancer; Sacituzumab govitecan; pembrolizumab; chemotherapy; low recurrence risk

Outcome Measures

Primary Outcomes (2)

• pathological complete remission (pCR)

  no invasive tumour in breast and lymph nodes (ypT0/is and ypN0)

  at surgery

• invasive disease-free survival rate (iDFS),

  time from date of first diagnosis to any invasive breast cancer event, death or secondary malignancy according to STEEP 2.0 criteria

  after 3 years

Secondary Outcomes (16)

• Overall survival (OS)

  6 years

• distant disease-free survival (dDFS)

  after 3 years

• distant disease-free interval (dDFI)

  after 3 years

• recurrence-free survival (RFS)

  after 3 years

• local recurrence-free survival (LRFS)

  after 3 years

Other Outcomes (2)

• Other pCR-definitions

  at time of surgery

• stromal tumour infiltrating lymphocytes (sTIL)

  at baseline and after 3 weeks of therapy

Study Arms (2)

Neoadjuvant treatment: 12 weeks (4 cycles) SG i.v.

EXPERIMENTAL

* Cohort 1a: In case of (near) cCR: end of treatment, followed by surgery * Cohort 1b: In case of cPR after 12 weeks: further 6 weeks (2 cycles) SG i.v., followed by surgery (use of core biopsy is allowed per investigator´s decision, if further NACT is planned) pCR dependent post-neoadjuvant treatment * In case of pCR: no further systemic treatment * In case of non-pCR: chemotherapy according to investigators decision, e.g., AC/EC q3w x 4, PAC/Carbo q1w x 12

Drug: Sacituzumab govitecan

Neoadjuvant treatment: 12 weeks (4 cycles) SG+PEM i.v.

EXPERIMENTAL

* Cohort 2a: In case of (near) cCR: end of treatment, followed by surgery * Cohort 2b: In case of cPR after 12 weeks: 6 weeks (2 cycles) SG+PEM i.v., followed by surgery (use of core biopsy is allowed per investigator´s decision, if further NACT is planned) pCR dependent post-neoadjuvant treatment * In case of pCR: no further systemic treatment * In case of non-pCR: chemotherapy according to investigators decision, e.g., AC/EC q3w x 4, PAC/Carbo q1w x 12

Drug: Sacituzumab govitecan; Drug: Pembrolizumab

Interventions

Sacituzumab govitecan DRUG

10 mg/kg twice on Days 1 and 8 of a continuous 21-day treatment cycle

Also known as: Trodelvy

Neoadjuvant treatment: 12 weeks (4 cycles) SG i.v.; Neoadjuvant treatment: 12 weeks (4 cycles) SG+PEM i.v.

Pembrolizumab DRUG

200 mg every 3 weeks (q3w)

Also known as: Keytruda

Neoadjuvant treatment: 12 weeks (4 cycles) SG+PEM i.v.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ER + PR negative or low positive (≤10% positive cells in IHC), and HER2 negative (i.e., IHC 0 - 1+ or IHC 2+ with FISH negative) breast cancer
• All patients, independent from gender
• ≥18 years at diagnosis
• Histologically confirmed unilateral, primary invasive carcinoma of the breast Note: bilateral, multicentric, or multifocal carcinoma may be included, if there is a clear target lesion, that is subject to treatment decisions and solely evaluated and documented for study purposes.
• Clinical stage I: cT1a-c, cN0 (clinical stage II only, if patient does not qualify for neoadjuvant polychemotherapy+PEM, e.g., elderly population, per investigator´s decision)
• No clinical evidence for distant metastasis (M0)
• Tumour block available for central pathology review
• Performance Status ECOG ≤ 1 or KI ≥ 80%
• Negative pregnancy test (urine or serum) within 7 days prior to registration in premenopausal patients
• Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
• The patient must be willing and able to comply with the requirements and restrictions in this protocol and accessible for treatment and follow-up
• Laboratory requirements:
• Leucocytes ≥3.5 109/L,
• Neutrophils \> 1.5 109/L,
• Platelets ≥100 109/L,

You may not qualify if:

• Known hypersensitivity reaction to the compounds or incorporated substances of the IMPs
• Prior malignancy with a disease-free survival of \< 5 years, except curatively treated basalioma of the skin or pTis of the cervix uteri
• Any history of invasive breast cancer
• Previous or concurrent treatment with cytotoxic agents for any non-oncological reason unless clarified with sponsor
• Concurrent treatment with other experimental drugs
• Participation in another interventional clinical trial with or without any investigational not marketed drug within 30 days prior to study entry
• Concurrent pregnancy; patients of childbearing potential or potentially childbearing partners of male patients must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
• Breast feeding woman
• Reasons indicating risk of poor compliance
• Patients not able to consent
• Known polyneuropathy ≥ grade 2
• Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including recovery from major surgery, autoimmune disease, known psychiatric/substance abuse disorders, acute cystitis, ischuria, and chronic kidney disease
• Uncontrolled infection requiring i.v. antibiotics, antivirals, or antifungals
• History of pneumonitis
• Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients should be tested for HIV prior to randomisation if required by local regulations or ethics committee (EC).

Sponsors & Collaborators

• West German Study Group: lead
• Gilead Sciences: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (42)

Stadtklinik Baden-Baden / Brustzentrum

Baden-Baden, Baden-Wurttemberg, 76532, Germany

RECRUITING

Kliniken Böblingen

Böblingen, Baden-Wurttemberg, 71032, Germany

RECRUITING

Praxis für interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, Baden-Wurttemberg, 79110, Germany

RECRUITING

SLK Kliniken Heilbronn, Frauenklinik

Heilbronn, Baden-Wurttemberg, 74078, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89075, Germany

RECRUITING

GRN Klinik Weinheim

Weinheim, Baden-Württembergs, 69469, Germany

RECRUITING

Hämatologie-Onkologie im Zentrum MVZ GmbH

Augsburg, Bavaria, 86150, Germany

RECRUITING

Universitätsklinikum Augsburg A.ö.R.

Augsburg, Bavaria, 86156, Germany

RECRUITING

Rotkreuzklinikum München

München, Bavaria, 80637, Germany

ACTIVE NOT RECRUITING

DBZ Onkologie GmbH

Berlin, Brandenburg, 12623, Germany

NOT YET RECRUITING

Klinikum Ernst von Bergmann gGmbH

Potsdam, Brandenburg, 14467, Germany

RECRUITING

Klinikum Bremerhaven Reinkenheide gGmbH

Bremerhaven, City state Bremen, 27574, Germany

ACTIVE NOT RECRUITING

AGAPLESION Markus Krankenhaus

Frankfurt am Main, Hesse, 60431, Germany

RECRUITING

MVZ II der Niels Stensen Kliniken

Georgsmarienhütte, Lower Saxony, 49124, Germany

RECRUITING

Gynäkologische Gemeinschaftspraxis-Ärztehaus am Bahnhofsplatz

Hildesheim, Lower Saxony, 31134, Germany

NOT YET RECRUITING

Ev. Krankenhaus Berlin-Spandau

Berlin, North Rhine-Westphalia, 13589, Germany

RECRUITING

Onkologische Schwerpunktpraxis Bielefeld

Bielefeld, North Rhine-Westphalia, 33604, Germany

RECRUITING

St. Elisabeth-Krankenhaus Köln-Hohenlind

Cologne, North Rhine-Westphalia, 50935, Germany

RECRUITING

Kliniken der Stadt Köln, Krankenhaus Holweide

Cologne, North Rhine-Westphalia, 51067, Germany

RECRUITING

MVZ Medical Center Düsseldorf - GynOnco

Düsseldorf, North Rhine-Westphalia, 40235, Germany

RECRUITING

St. - Antonius - Hospital

Eschweiler, North Rhine-Westphalia, 52249, Germany

RECRUITING

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45130, Germany

RECRUITING

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45136, Germany

RECRUITING

ev. Klinikum Gelsenkirchen - Klinik für Senelogie

Gelsenkirchen, North Rhine-Westphalia, 45879, Germany

RECRUITING

St. Barbara Klinik Hamm GmbH

Hamm, North Rhine-Westphalia, 59073, Germany

RECRUITING

Klinikum Leverkusen gGmbH

Leverkusen, North Rhine-Westphalia, 51375, Germany

RECRUITING

Ev. Krankenhaus Bethesda Brustzentrum Niederrhein

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

RECRUITING

MVZ MediaVita, St. Franziskus-Hospital Münster

Münster, North Rhine-Westphalia, 48145, Germany

RECRUITING

MKS St.Paulus GmbH (ehem.Marienkrankenhaus)

Schwerte, North Rhine-Westphalia, 58239, Germany

RECRUITING

Praxisnetzwerk Hämatologie und Onkologie, Troisdorf

Troisdorf, North Rhine-Westphalia, 53840, Germany

RECRUITING

Marien Hospital Witten

Witten, North Rhine-Westphalia, 58452, Germany

RECRUITING

Helios Universitätsklinikum Wuppertal Barmen

Wuppertal, North Rhine-Westphalia, 42283, Germany

RECRUITING

Klinikum Mutterhaus-Trier

Trier, Rhineland-Palatinate, 54290, Germany

RECRUITING

Caritasklinikum Saarbrücken

Saarbrücken, Saarland, 66113, Germany

NOT YET RECRUITING

Johanniter GmbH Johanniter Krankenhaus Stendal

Stendal, Sachsen-Anhalts, 39576, Germany

RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, 09116, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Charité Campus Mitte Universitätsklinikum Berlin

Berlin, 10117, Germany

NOT YET RECRUITING

Hämatologisch/Onkologische Schwerpunktpraxis Bremen

Bremen, 28209, Germany

RECRUITING

Mammazentrum Hamburg am Krankenhaus Jerusalem

Hamburg, 20357, Germany

RECRUITING

Klinikum der Universität München

München, 80336, Germany

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Interventions

sacituzumab govitecan; pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter Schmid, Prof Dr PHD

  Westdeutsche Studiengruppe GmbH

  PRINCIPAL INVESTIGATOR

• Nadia Harbeck, Prof Dr

  Breast Centre, Dept. Obstetrics & Gynaecology and CCC Munich LMU University Hospital

  PRINCIPAL INVESTIGATOR

• Oleg Gluz, PD Dr

  Breast Centre, Evang. Bethesda-Hospital, Moenchengladbach

  PRINCIPAL INVESTIGATOR

• Sherko Kuemmel, Prof Dr

  Breast Centre, Kliniken Essen Mitte

  PRINCIPAL INVESTIGATOR

• Monika Graeser, PD Dr..

  Breast Centre, Evang. Bethesda-Hospital, Moenchengladbach

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oleg Gluz, PD Dr.

CONTACT

+492161566230; oleg.gluz@wsg-online.com

Anja Braschoß

CONTACT

+4917682119153; anja.braschoss@wsg-online.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicentre, interventional, prospective, two-arm, randomised, open-label, neoadjuvant, phase-II-trial evaluating the efficacy and safety of SG alone vs. SG+PEM in low-risk early TNBC in pre- and postmenopausal women.

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: October 13, 2023
• Study Start: October 10, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (42)