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Testing two different drugs (sacituzumab-govitecan and trastuzumab-deruxtecan) combinations prescribed in an alterning pattern to patients with metastatic or locally advanced triple-negative breast cancer
EU CTIS ID: 2025-521909-40-00
What this study is testing
To demonstrate the superiority in terms of overall survival of the SG and T-DXd combinations in an upfront alternating scheme as first line of antibody-drug conjugates in HER2-low mTNBC over SG alone.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient must have signed a written informed consent prior to any trial specific procedures.
- Affiliated to the French Social Security System (or equivalent).
- Patient willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
- Men or women ≥ 18 years of age;
- Histologically confirmed metastatic or locally advanced and unresectable triple negative breast cancer that meets both of the following criteria by local testing: • HER2-low breast cancer (BC) with documented evidence of HER2-low defined as: [immunohistochemistry (IHC) 2+/in situ hybridization (ISH)- or IHC 1+ (ISH- or untested)] on either the primary or any metastatic site • With Estrogen Receptor expression <10% AND Progesterone Receptor expression <10%,
- Patient eligible to receive sacituzumab-govitecan and T-Dxd according to their indication
You likely can't join if
- Previously treated with any ADC targeting HER2 or TROP2
- Pregnant or breast-feeding women at the time of randomization or intention to become pregnant during the study and up to 7 months after treatment
- Person deprived of their liberty or under protective custody or guardianship
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.
- Uncontrolled or significant cardiovascular disease
- Patients with brain metastases (BM) except for asymptomatic treated BM not requiring ongoing corticosteroid treatment with stable lesions on baseline/screening brain MRI. Patients who require treatment of brain metastases are eligible after 14 days post surgery or radiation, if felt to be clinically stable and not requiring ongoing corticosteroid treatment
See the full eligibility criteria
Who can join
- Patient must have signed a written informed consent prior to any trial specific procedures.
- Affiliated to the French Social Security System (or equivalent).
- Patient willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
- Men or women ≥ 18 years of age;
- Histologically confirmed metastatic or locally advanced and unresectable triple negative breast cancer that meets both of the following criteria by local testing: • HER2-low breast cancer (BC) with documented evidence of HER2-low defined as: [immunohistochemistry (IHC) 2+/in situ hybridization (ISH)- or IHC 1+ (ISH- or untested)] on either the primary or any metastatic site • With Estrogen Receptor expression <10% AND Progesterone Receptor expression <10%,
- Patient eligible to receive sacituzumab-govitecan and T-Dxd according to their indication
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Woman of childbearing potential and male patients must agree to use adequate contraception for the duration of trial participation and up to 7 months after completing the study treatment for women and up to 4 months for men..
- Adequate organ and bone marrow functions within 28 days before enrollment. For all parameters listed below, the most recent results available must be used • Hemoglobin ≥ 9 g/dL. Note: Red blood cell transfusion is not allowed within 1 week prior to screening assessment. • Absolute neutrophil count (ANC) ≥ 1500/mm3. Note: Granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment. • Platelet count ≥ 100,000/mm3. Note: Platelet transfusion is not allowed within 1 week prior to registration. • Total bilirubin ≤ 1.5 × upper limit of normal (ULN) if no liver metastases or < 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastasis at baseline. • Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 ×ULN or < 5 × ULN in patients with liver metastasis. • Serum albumin ≥ 2.5 g/dL. • Creatinine clearance (CrCl) ≥ 30 mL/min (calculated using the Cockcroft and Gault equation). Cockcroft-Gault equation: CrCl (mL/min) = [140 - age (years)] × weight (kg) 72 × serum creatinine (mg/dL) {× 0.85 for females}.
- Adequate cardiac function, defined as a left ventricular ejection fraction ≥ 55% estimated by echocardiogram or multigated acquisition scintigraphy.
- Women of childbearing potential must have a negative serum or urine pregnancy test done within 7 days before randomization.
What rules you out
- Previously treated with any ADC targeting HER2 or TROP2
- Pregnant or breast-feeding women at the time of randomization or intention to become pregnant during the study and up to 7 months after treatment
- Person deprived of their liberty or under protective custody or guardianship
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.
- Uncontrolled or significant cardiovascular disease
- Patients with brain metastases (BM) except for asymptomatic treated BM not requiring ongoing corticosteroid treatment with stable lesions on baseline/screening brain MRI. Patients who require treatment of brain metastases are eligible after 14 days post surgery or radiation, if felt to be clinically stable and not requiring ongoing corticosteroid treatment
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Any medical history or condition that per protocol or in the opinion of the investigator is incompatible with the study.
- Patients with known allergy or severe hypersensitivity to any of the trial drugs or their excipients
- Other concurrent medical or psychiatric condition that, in the Investigator's opinion, may cause misleading study interpretation or prevent completion of study procedures and followup examinations.
- Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment are not eligible.
- Participation in another clinical study that resulted in the administration of one or more investigational medicinal products within 30 days prior to randomization or within 5 half-lives of the investigational medicinal product(s) (whichever is longer)
The study team makes the final eligibility decision.
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 all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.