Actively Recruiting
NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)
Led by West German Study Group · Updated on 2025-11-19
348
Participants Needed
42
Research Sites
255 weeks
Total Duration
On this page
Sponsors
W
West German Study Group
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female with ER and PR negative or low positive (≤10% positive cells) and HER2 negative breast cancer
- Age 18 years or older at diagnosis
- Histologically confirmed unilateral primary invasive breast cancer
- Clinical stage I: tumor size cT1a-c, node negative (cN0); stage II only if not qualifying for polychemotherapy+Pembrolizumab
- No clinical evidence of distant metastases (M0)
- Tumor sample available for central pathology review
- ECOG performance status ≤1 or Karnofsky Index ≥80%
- Negative pregnancy test within 7 days prior to registration for premenopausal patients
- Willingness and ability to comply with study treatment and follow-up
- Laboratory values within required limits including leucocytes ≥3.5 x 10^9/L, neutrophils >1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥10 g/dL, AP <5.0 ULN, AST and ALT ≤2.5 x ULN, total bilirubin ≤1 x ULN, creatinine ≤1.5 x ULN or clearance ≥30 mL/min
- Normal left ventricular ejection fraction and ECG within 42 days prior to treatment
- Post-menopausal status as defined by amenorrhea and hormone levels depending on age
- Use of effective contraception for women of childbearing potential and male participants during and 7 months after treatment
- Informed consent obtained
You will not qualify if you...
- Known allergy to study drugs or their components
- Previous invasive breast cancer or malignancy within 5 years (except certain treated skin or cervical conditions)
- Previous cytotoxic treatment for non-cancer reasons unless approved
- Concurrent use of other experimental drugs
- Participation in another interventional trial within 30 days prior to enrollment
- Pregnancy or breastfeeding
- Poor compliance risk or inability to consent
- Known polyneuropathy grade 2 or higher
- Severe comorbidities affecting cytotoxic treatment or study participation
- Uncontrolled infections requiring intravenous therapy
- History of pneumonitis
- Active primary immunodeficiency, HIV infection, or active hepatitis B or C
- Positive viral loads for hepatitis B or C
- Positive HIV antibody test
AI-Screening
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Trial Site Locations
Total: 42 locations
1
Stadtklinik Baden-Baden / Brustzentrum
Baden-Baden, Baden-Wurttemberg, Germany, 76532
Actively Recruiting
2
Kliniken Böblingen
Böblingen, Baden-Wurttemberg, Germany, 71032
Actively Recruiting
3
Praxis für interdisziplinäre Onkologie & Hämatologie
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79110
Actively Recruiting
4
SLK Kliniken Heilbronn, Frauenklinik
Heilbronn, Baden-Wurttemberg, Germany, 74078
Active, Not Recruiting
5
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
6
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany, 89075
Actively Recruiting
7
GRN Klinik Weinheim
Weinheim, Baden-Württembergs, Germany, 69469
Actively Recruiting
8
Hämatologie-Onkologie im Zentrum MVZ GmbH
Augsburg, Bavaria, Germany, 86150
Actively Recruiting
9
Universitätsklinikum Augsburg A.ö.R.
Augsburg, Bavaria, Germany, 86156
Actively Recruiting
10
Rotkreuzklinikum München
München, Bavaria, Germany, 80637
Active, Not Recruiting
11
DBZ Onkologie GmbH
Berlin, Brandenburg, Germany, 12623
Not Yet Recruiting
12
Klinikum Ernst von Bergmann gGmbH
Potsdam, Brandenburg, Germany, 14467
Actively Recruiting
13
Klinikum Bremerhaven Reinkenheide gGmbH
Bremerhaven, Free Hanseatic City of Bremen, Germany, 27574
Active, Not Recruiting
14
AGAPLESION Markus Krankenhaus
Frankfurt am Main, Hesse, Germany, 60431
Actively Recruiting
15
MVZ II der Niels Stensen Kliniken
Georgsmarienhütte, Lower Saxony, Germany, 49124
Actively Recruiting
16
Gynäkologische Gemeinschaftspraxis-Ärztehaus am Bahnhofsplatz
Hildesheim, Lower Saxony, Germany, 31134
Not Yet Recruiting
17
Ev. Krankenhaus Berlin-Spandau
Berlin, North Rhine-Westphalia, Germany, 13589
Actively Recruiting
18
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, North Rhine-Westphalia, Germany, 33604
Actively Recruiting
19
St. Elisabeth-Krankenhaus Köln-Hohenlind
Cologne, North Rhine-Westphalia, Germany, 50935
Actively Recruiting
20
Kliniken der Stadt Köln, Krankenhaus Holweide
Cologne, North Rhine-Westphalia, Germany, 51067
Actively Recruiting
21
MVZ Medical Center Düsseldorf - GynOnco
Düsseldorf, North Rhine-Westphalia, Germany, 40235
Actively Recruiting
22
St. - Antonius - Hospital
Eschweiler, North Rhine-Westphalia, Germany, 52249
Actively Recruiting
23
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany, 45130
Actively Recruiting
24
Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, Germany, 45136
Actively Recruiting
25
ev. Klinikum Gelsenkirchen - Klinik für Senelogie
Gelsenkirchen, North Rhine-Westphalia, Germany, 45879
Actively Recruiting
26
St. Barbara Klinik Hamm GmbH
Hamm, North Rhine-Westphalia, Germany, 59073
Actively Recruiting
27
Klinikum Leverkusen gGmbH
Leverkusen, North Rhine-Westphalia, Germany, 51375
Actively Recruiting
28
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein
Mönchengladbach, North Rhine-Westphalia, Germany, 41061
Actively Recruiting
29
MVZ MediaVita, St. Franziskus-Hospital Münster
Münster, North Rhine-Westphalia, Germany, 48145
Actively Recruiting
30
MKS St.Paulus GmbH (ehem.Marienkrankenhaus)
Schwerte, North Rhine-Westphalia, Germany, 58239
Actively Recruiting
31
Praxisnetzwerk Hämatologie und Onkologie, Troisdorf
Troisdorf, North Rhine-Westphalia, Germany, 53840
Actively Recruiting
32
Marien Hospital Witten
Witten, North Rhine-Westphalia, Germany, 58452
Actively Recruiting
33
Helios Universitätsklinikum Wuppertal Barmen
Wuppertal, North Rhine-Westphalia, Germany, 42283
Actively Recruiting
34
Klinikum Mutterhaus-Trier
Trier, Rhineland-Palatinate, Germany, 54290
Actively Recruiting
35
Caritasklinikum Saarbrücken
Saarbrücken, Saarland, Germany, 66113
Not Yet Recruiting
36
Johanniter GmbH Johanniter Krankenhaus Stendal
Stendal, Sachsen-Anhalts, Germany, 39576
Actively Recruiting
37
Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany, 09116
Active, Not Recruiting
38
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany, 04103
Actively Recruiting
39
Charité Campus Mitte Universitätsklinikum Berlin
Berlin, Germany, 10117
Not Yet Recruiting
40
Hämatologisch/Onkologische Schwerpunktpraxis Bremen
Bremen, Germany, 28209
Actively Recruiting
41
Mammazentrum Hamburg am Krankenhaus Jerusalem
Hamburg, Germany, 20357
Actively Recruiting
42
Klinikum der Universität München
München, Germany, 80336
Actively Recruiting
Research Team
O
Oleg Gluz, PD Dr.
CONTACT
A
Anja Braschoß
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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