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Tests treatment safety and results for BREAST CANCER
Official title Phase 4 Study to Assess the Safety of Trastuzumab Deruxtecan, in Indian Patients
ClinicalTrials.gov ID: NCT06429761
What this study is testing
What is Trastuzumab deruxtecan?
Trastuzumab deruxtecan is an investigational medicine, given as an infusion into a vein, 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
- A PROSPECTIVE, MULTI-CENTER, PHASE 4, SINGLE ARM STUDY TO ASSESS THE SAFETY OF TRASTUZUMAB DERUXTECAN, AN ANTI-HER2-ANTIBODY DRUG CONJUGATE IN INDIAN PATIENTS WITH UNRESECTABLE OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED A PRIOR ANTI-HER2-BASED REGIMEN
- Phase 4: studies an already-approved treatment
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
- 1 Participant must be \>18 years of age inclusive, at the time of signing the informed consent. 2 Patients who are willing and capable of giving...
- is unresectable or metastatic
- HER2-positive expression (IHC 3+ or IHC 2+ with ISH positive) as confirmed by laboratory assessment within last 1 year of study enrolment.
- was previously treated with an anti HER-2 based regimen 4 Adequate bone marrow function, within 14 d before enrolment, defined as: a. Absolute...
- Creatinine clearance ≥ 30 mL/min, as calculated using the Cockcroft-Gault equation (CLcr (mL/min) = [140 - age (years)] × weight (kg) {× 0.85 for...
You likely can't join if
- Prior treatment with T-DXd
- Uncontrolled or significant cardiovascular disease, including any of the following:
- History of myocardial infarction within 6 months before enrolment
- History of symptomatic congestive heart failure (New York Heart Association Class II to IV);
- Corrected QT interval (QTc) prolongation to \> 470 ms (females) or \>450 ms (male);
- LVEF \< 50% within 28 d prior to treatment initiation.
See the full eligibility criteria
- 1 Participant must be \>18 years of age inclusive, at the time of signing the informed consent. 2 Patients who are willing and capable of giving signed informed consent as described in Appendix A, which includes...
- is unresectable or metastatic
- HER2-positive expression (IHC 3+ or IHC 2+ with ISH positive) as confirmed by laboratory assessment within last 1 year of study enrolment.
- was previously treated with an anti HER-2 based regimen 4 Adequate bone marrow function, within 14 d before enrolment, defined as: a. Absolute neutrophil count ≥ 1.5 × 109/L (granulocyte colony-stimulating factor...
- Creatinine clearance ≥ 30 mL/min, as calculated using the Cockcroft-Gault equation (CLcr (mL/min) = [140 - age (years)] × weight (kg) {× 0.85 for females}; 72 × serum creatinine (mg/dL) 6 Adequate hepatic function...
- 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 metastases at baseline, and
- Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 × ULN 7 Adequate blood clotting function within 14 d before enrolment, defined as:
- International normalized ratio/prothrombin time ≤ 1.5 × ULN and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN 8 Female people of reproductive/childbearing potential must agree to use...
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o Oral o Intravaginal o Transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation: o Oral o Injectable o Implantable
- Intrauterine device
- Intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Vasectomized partner
- Complete sexual abstinence defined as refraining from heterosexual intercourse during and upon completion of the study and for at least 7 mo for female people (4.5 mo for male people) after the last dose of trastuzumab...
- Prior treatment with T-DXd
- Uncontrolled or significant cardiovascular disease, including any of the following:
- History of myocardial infarction within 6 months before enrolment
- History of symptomatic congestive heart failure (New York Heart Association Class II to IV);
- Corrected QT interval (QTc) prolongation to \> 470 ms (females) or \>450 ms (male);
- LVEF \< 50% within 28 d prior to treatment initiation.
- Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
- Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
- people with clinically inactive brain metastases may be included in the study.
- people with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of...
- Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product or to other mAbs.
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- Known human immunodeficiency virus (HIV) infection or active hepatitis B or C infection.
- Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. people with chronic Grade 2 toxicities may be eligible per the discretion of...
- Therapeutic radiation therapy or major surgery within 4 wk before enrolment or palliative stereotactic radiation therapy within 2 wk before enrolment.
- Systemic treatment with anticancer therapy (immunotherapy [non-antibody-based therapy], retinoid therapy, or hormonal therapy) within 3 wk before enrolment; antibody-based-anticancer-therapy within 4 wk before...
- Participation in a therapeutic clinical study within 3 wk before enrolment (for small-molecule targeted agents, this non-participation period is 2 wk or 5 half-lives, whichever is longer), or current participation in...
- Pregnant, breastfeeding, or planning to become pregnant.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment...
The study team makes the final eligibility decision.
Where it's taking place
- Bangalore, India
- Delhi, India
- Kochi, India
- Mumbai, India
- Pune, India
- Varanasi, India
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 Bangalore, India; Delhi, India; Kochi, India; Mumbai, India; Pune, India; Varanasi, India. 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.