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Tests treatment safety and results for Breast Cancer
Official title A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer
ClinicalTrials.gov ID: NCT06508216
What this study is testing
What is Dato-DXd?
Dato-DXd is an investigational medicine, being studied as a potential treatment for breast cancer.
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
- Choice Of the Most Active Strategies for Short term recurring Triple Negative Breast Cancer: A phase Ib/II, open-label, modular, dose-finding and dose-expansion study to explore safety, tolerability, pharmacokinetics, and anti-tumor activity of novel therapeutics in patients with early relapsed metastatic triple-negative breast cancer
- Phase 2: a mid-size study of how well it works
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
You may be able to join if
- Male or female patients (who are ≥18 years of age at the time of signing the informed consent) who have a pathologically documented breast cancer...
- Advanced/unresectable (patients who can be treated with curative intent are not eligible) or metastatic.
- HER2-negative (IHC 0, 1+ or IHC 2+/ISH-) based on local assessment according to ASCO/CAP guidelines 1.
- Documented as hormone receptor-negative (both oestrogen receptors and progesterone receptors are negative [oestrogen receptors and progesterone...
- Patients need to provide an adequate tissue sample: provided from either a new biopsy of a metastatic site or the most recent archival biopsy taken...
You likely can't join if
- Evidence of untreated spinal cord compression or with leptomeningeal or brain metastases, requiring more than 10 mg/day of prednisone or equivalent...
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease...
- Has a clinically significant corneal disease.
- Has a history of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected...
- Uncontrolled or significant lung disease or prior pneumonectomy.
- Active connective tissue or inflammatory disorders requiring treatment, or active or prior documented autoimmune disease within the past 5 years. Of...
See the full eligibility criteria
Who can join
- Male or female patients (who are ≥18 years of age at the time of signing the informed consent) who have a pathologically documented breast cancer that is:
- Advanced/unresectable (patients who can be treated with curative intent are not eligible) or metastatic.
- HER2-negative (IHC 0, 1+ or IHC 2+/ISH-) based on local assessment according to ASCO/CAP guidelines 1.
- Documented as hormone receptor-negative (both oestrogen receptors and progesterone receptors are negative [oestrogen receptors and progesterone receptors \< 10%]) as per GEFPICS guidelines in the metastatic setting 2.
- Patients need to provide an adequate tissue sample: provided from either a new biopsy of a metastatic site or the most recent archival biopsy taken at the time of diagnosis of metastatic disease, if performed within 1...
- Patients who have early relapsed triple negative breast cancer i.e.:
- Patients who have received neo/adjuvant chemotherapy in the localized stage.
- Radiological and anatomopathological evidence of disease recurrence or metastasis while on (neo)adjuvant treatment or within 12 months from the end of all treatments with curative intent.
- Patients with germinal pathological BRCA1/2 mutations are eligible to the study if they have received prior treatment with PARP inhibitor.
- ECOG PS of 0 to 2.
- LVEF ≥ 50% within 28 days before enrolment.
- Adequate organ and bone marrow function within 14 days prior to treatment assignment.
- At least one lesion, not previously irradiated (and different from the biopsy site), that qualifies as a RECIST 1.1 target lesion at baseline.
- An adequate treatment washout period before randomization/enrolment.
- Patients with leptomeningeal or brain metastases can be included in the trial if symptoms are controlled with corticosteroids until 10 mg/day of prednisone or equivalent. Patients with brain metastases must receive...
- Evidence of post-menopausal status or negative serum pregnancy test for females of child-bearing potential who are sexually active with a non-sterilized male partner. For women of child-bearing potential, a negative...
- Women \< 50 years of age would 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 and...
- Women ≥ 50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last...
- Women who are surgically sterile (i.e., bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) are eligible.
- Female patients of child-bearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from the time of screening and must agree to continue...
- Non-sterilized male patients who are sexually active with a female partner of child-bearing potential must use a condom with spermicide from screening to 4 months after the final dose of study treatment. Not engaging in...
- Female patients must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study treatment administration...
- Patient must understand, sign and date the written informed consent form (ICF) prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedure as per...
- Patient must be affiliated to a social security system or beneficiary of the same.
What rules you out
- Evidence of untreated spinal cord compression or with leptomeningeal or brain metastases, requiring more than 10 mg/day of prednisone or equivalent. Note: Untreated spinal cord compression: patients can enter the study...
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, severe pulmonary function compromise, serious chronic gastrointestinal...
- Has a clinically significant corneal disease.
- Has a history of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Uncontrolled or significant lung disease or prior pneumonectomy.
- Active connective tissue or inflammatory disorders requiring treatment, or active or prior documented autoimmune disease within the past 5 years. Of note, patients with vitiligo, Grave's disease or psoriasis not...
- Active primary immunodeficiency.
- Has active or uncontrolled hepatitis B or C virus infection. Patients are eligible if they:
- Have been curatively treated for HCV infection as demonstrated clinically and by viral serologies
- Have received HBV vaccination with only anti-HBs positivity and no clinical signs of hepatitis
- Are HBsAg- and anti-HBc+ (i.e., those who have cleared HBV after infection) and meet conditions i-iii of criterion d below:
- Are HBsAg+ with chronic HBV infection (lasting 6 months or longer) and meet conditions i-iii below: i. HBV DNA viral load \< 2000 IU/mL ii. Have normal transaminase values, or, if liver metastases are present, abnormal...
- Patients with known controlled HIV infection and undetectable HIV-DNA are eligible to the trial. Note: all of the following criteria are required to define an HIV infection that is well controlled: undetectable viral...
- Any concurrent systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy..), radiotherapy, investigational agent , or biological therapy for cancer treatment. Concurrent use of hormonal therapy for...
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of study treatment.
- Adequately treated non-melanoma skin cancer or Lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- Has a history of severe hypersensitivity reactions to either the study treatment(s) or inactive ingredients (including but not limited to polysorbate 80 of Dato-DXd), or has a history of severe hypersensitivity...
- Patients having received prior treatment with any antibody drug conjugates targeting TROP2 (eg, Sacituzumab govitecan) are not eligible to the study.
- Judgment by the Investigator that the patients should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
- History of allogeneic organ transplantation.
- Patient has clinically significant, uncontrolled heart disease and/or recent cardiac events including any of the following:
- History of angina pectoris, coronary artery bypass graft (CABG), symptomatic pericarditis, or myocardial infarction within 12 months prior to the start of study treatment.
- History of documented congestive heart failure (New York Heart Association functional classification III-IV).
- Documented cardiomyopathy.
- Patient has a Left Ventricular Ejection Fraction (LVEF) \< 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO).
- History of any cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block), supraventricular, nodal...
- Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100 mmHg, with or without antihypertensive medication. Initiation or adjustment of antihypertensive...
- Patients with prior use of immunosuppressive medications within 14 days prior to first study drug dose or anticipation of need for systemic immunosuppressive medication during study treatment, except for intranasal and...
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 7 months after the last dose of study...
- Administration of live attenuated vaccines within 30 days prior to the first dose of study treatment, or anticipation that such a live, attenuated vaccine will be required during the study or within 3 months after the...
- Persons deprived of their freedom or under guardianship, or for whom it would be impossible to undergo the medical follow-up required by the trial, for geographic, social or psychological reasons.
- Participation in another clinical study with an investigational product during the last 4 weeks prior to enrollment and while on study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Villejuif, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Villejuif, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.