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Compares treatment options for Triple Negative Breast Cancer
Official title NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)
ClinicalTrials.gov ID: NCT06081244
What this study is testing
What is Sacituzumab govitecan?
Sacituzumab govitecan is an investigational medicine, given as an once-weekly, being studied as a potential treatment for triple negative breast cancer.
Also referred to as Trodelvy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- Clinical stage I: cT1a-c, cN0 (clinical stage II only, if patient does not qualify for neoadjuvant polychemotherapy+PEM, e.g., elderly population...
You likely can't join 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 treatment clinical trial with or without any investigational not marketed drug within 30 days prior to study entry
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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,
- Haemoglobin ≥10 g/dL,
- AP \< 5.0 ULN,
- AST ≤2.5 x ULN,
- ALT ≤2.5 x ULN,
- Total bilirubin ≤1 x ULN,
- Creatinine ≤1.5 × ULN OR clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
- Clinical assessments:
- LVEF within normal limits of each institution, measured by echocardiography and normal ECG (within 42 days prior to treatment)
- The following age-specific requirements apply:
- Women aged \<50 years will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone (LH) and...
- Women aged ≥ 50 years will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments.
- Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their...
- Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 1 (see Section 4.4.2), from the...
- Female patients must not donate, or retrieve for their own use, ova from the time of randomisation and throughout the study treatment period, and for at least 7 months after the final study drug administration. They...
- A male participant must agree to use a contraception as detailed in Appendix C of this protocol during the treatment period and for at least 7 months after the last dose of study treatment and refrain from donating...
What rules you out
- 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 treatment 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...
- 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...
- 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...
- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.
- Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for...
- Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require a HCV...
- Patients who test positive for HIV antibody.
The study team makes the final eligibility decision.
Where it's taking place
- Baden-Baden, Baden-Wurttemberg, Germany
- Böblingen, Baden-Wurttemberg, Germany
- Freiburg im Breisgau, Baden-Wurttemberg, Germany
- Heilbronn, Baden-Wurttemberg, Germany
- Tübingen, Baden-Wurttemberg, Germany
- Ulm, Baden-Wurttemberg, Germany
- Weinheim, Baden-Württembergs, Germany
- Augsburg, Bavaria, Germany
- München, Bavaria, Germany
- Berlin, Brandenburg, Germany
- Potsdam, Brandenburg, Germany
- Bremerhaven, Free Hanseatic City of Bremen, Germany
- Frankfurt am Main, Hesse, Germany
- Georgsmarienhütte, Lower Saxony, Germany
- Hildesheim, Lower Saxony, Germany
- Berlin, North Rhine-Westphalia, Germany
- Bielefeld, North Rhine-Westphalia, Germany
- Cologne, North Rhine-Westphalia, Germany
- Düsseldorf, North Rhine-Westphalia, Germany
- Eschweiler, North Rhine-Westphalia, Germany
+ 19 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baden-Baden, Baden-Wurttemberg, Germany; Böblingen, Baden-Wurttemberg, Germany; Freiburg im Breisgau, Baden-Wurttemberg, Germany; Heilbronn, Baden-Wurttemberg, Germany; Tübingen, Baden-Wurttemberg, Germany; Ulm, Baden-Wurttemberg, Germany and 33 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.