Resumen

Los investigadores desean saber si sacituzumab tirumotecan administrado solo o con pembrolizumab puede tratar el cáncer de mama triple negativo (CMTN). El objetivo principal de este estudio es determinar si las personas tratadas con sacituzumab tirumotecan solo o con pembrolizumab viven más tiempo en total o sin que el cáncer crezca o se disemine en comparación con las personas tratadas con quimioterapia.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent
Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer
Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence
Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin
Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Criterios de exclusión

Has breast cancer amenable to treatment with curative intent
Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10
Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer
Has Grade ≥2 peripheral neuropathy
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has skin only metastatic disease
Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications
Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has known additional malignancy that is progressing or has required active treatment within the past 5 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable
Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
History of stem cell/solid organ transplant
Has not adequately recovered from major surgery or has ongoing surgical complications

Intervenciones

biological

Sacituzumab tirumotecan

IV Infusion

biological

Pembrolizumab

IV Infusion

drug

Rescue Medication

Participants receive the following pre-medications before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion. Participants are also recommended to receive prophylactic steroid mouthwash (dexamethasone or equivalent).

drug

Paclitaxel

IV Infusion

drug

Nab-paclitaxel

IV Infusion

drug

Gemcitabine

IV Infusion

drug

Carboplatin

IV Infusion

Ubicaciones

Instituto de Investigaciones Clinicas Mar del Plata ( Site 2401)

Mar del Plata, Buenos Aires, Argentina

Study Coordinator · +54 9223 593 7663

RECRUITING

Instituto Alexander Fleming ( Site 2402)

Mar del Plata, Buenos Aires, Argentina

Study Coordinator · +541132218900

RECRUITING

Hospital Italiano de Cordoba ( Site 2406)

Córdoba, Córdoba Province, Argentina

Study Coordinator · +543514106550

RECRUITING

Clinica Viedma ( Site 2403)

Viedma, Río Negro Province, Argentina

Study Coordinator · 54 9351 592 3598

RECRUITING

Fundacion Estudios Clinicos ( Site 2405)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +54 9346 69 9922

RECRUITING

Hospital Provincial del Centenario ( Site 2410)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +543414307185

RECRUITING

Fundacion Centro Oncologico de Integración Regional ( Site 2400)

Mendoza, Argentina

Study Coordinator · +54 9261 367 9497

RECRUITING

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Sacituzumab tirumotecan

Pembrolizumab

Rescue Medication

Paclitaxel

Nab-paclitaxel

Gemcitabine

Carboplatin

Ubicaciones

Instituto de Investigaciones Clinicas Mar del Plata ( Site 2401)

Instituto Alexander Fleming ( Site 2402)

Hospital Italiano de Cordoba ( Site 2406)

Clinica Viedma ( Site 2403)

Fundacion Estudios Clinicos ( Site 2405)

Hospital Provincial del Centenario ( Site 2410)

Fundacion Centro Oncologico de Integración Regional ( Site 2400)

Patrocinadores

Contactos

Toll Free Number