Uno studio sulla chemioterapia con camrelizumab più in combinazione con o senza famitinib come terapia neoadiuvante nelle partecipanti con carcinoma mammario triplo negativo (TNBC) (BCTOP-T-N01)
Uno studio randomizzato, in aperto, multicentrico di fase III su camrelizumab più chemioterapia in combinazione con o senza famitinib come terapia neoadiuvante in partecipanti con carcinoma mammario triplo negativo (TNBC)
This is an open, randomized, controlled, multicenter Phase III clinical study. Eligible subjects were randomly assigned 1:1 to albumin-paclitaxel plus carboplatin and carrilizumab with or without famitinib neoadjuvant therapy. Stratification was performed at randomization according to the following factor: clinical stage of the tumor (stage II; Stage III) . Subjects who have completed neoadjuvant therapy and are suitable for surgery are required to undergo surgery. Subjects in the experimental group will continue to receive carrilizumab and famitinib until one year from the start of neoadjuvant therapy, and subjects in the control group will continue to receive carrilizumab until one year from the start of neoadjuvant therapy.
Subjects who completed neoadjuvant therapy were required to undergo imaging efficacy evaluation according to RECIST1.1 before surgery; subjects suitable for surgery received surgical treatment, and pathological evaluation of tumor efficacy was performed after surgery.
During the study treatment, if the subjects show disease progression, toxicity intolerance, withdrawal of informed consent, or the investigator determines that medication must be terminated, the study treatment will be terminated, and follow-up will continue, including disease recurrence and metastasis and safety follow-up.
Participants who complete surgical treatment will be followed for at least 2 years for event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival (DDFS), and safety assessment. Safety data should be collected from the signing of the informed consent until 28 days after the end of the study.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: chen li, MD
- Numero di telefono: +86-021-64175590
- Email: chen_li@fudan.edu.cn
Luoghi di studio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200032
- Reclutamento
- Breast cancer institute of Fudan University Cancer Hospital
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Contatto:
- Zhi-Ming Shao, MD
- Numero di telefono: 86-21-641755901105
- Email: zhimingshao@yahoo.com
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Contatto:
- Lei Fan, MD
- Numero di telefono: 86-21-641755901105
- Email: cmchen@medmail.com.cn
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Investigatore principale:
- Zhi-Ming Shao, MD
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Sub-investigatore:
- Li CHEN, MD
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Shanghai, Shanghai Municipality, Cina, 200032
- Reclutamento
- Fudan University Shanghai Cancer Center Shanghai, China, 200032
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Contatto:
- Zhimin Shao, M.D.
- Numero di telefono: 88807 +86-021-64175590
- Email: zhimingshao@yahoo.com
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Contatto:
- Linxiaoxi Ma, M.D
- Numero di telefono: 63169 +86-021-64175590
- Email: mary2008white@126.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Inclusion Criteria:
ECOG Performance Status of 0-1. Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
Tumor stage: II-III. Adequate hematologic and organ function. Must be willing to use an adequate method of contraception for the course of the study.
Exclusion Criteria:
- Has a history of breast cancer. Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4].
Has a diagnosis of immunodeficiency or autoimmune diseases. Has received any form of immunosuppressive therapy within 4 weeks prior to the first dose of study treatment.
Severe pulmonary or cardiac disease. Known active hepatitis C virus, or known active hepatitis B virus. History of organ or bone marrow transplantation. Pregnant or breast-feeding women. Patients who have previously received VEGFR-like small molecule tyrosine kinase inhibitors (such as famitinib, sorafenib, Sunitinib, regorafenib, etc.) (except bevacizumab); Urine routine indicated urinary protein ≥2+ and confirmed urinary protein quantity > 1g at 24h;
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Arm A
Camrelizumab Plus Chemotherapy and Famitinib |
camrelizumab+chemotherapy (Albumin-paclitaxel plus carboplatin)+Famitinib
Altri nomi:
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Comparatore attivo: Arm B
Camrelizumab Plus Chemotherapy |
Camrelizumab Plus Chemotherapy |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pathological complete response (pCR) rate
Lasso di tempo: Up to approximately 24 weeks
|
the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery |
Up to approximately 24 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Numero di responder valutati in base ai criteri di valutazione della risposta modificati nei tumori solidi (RECIST v1.1) per le lesioni bersaglio valutate mediante risonanza magnetica.
Lasso di tempo: Fino a circa 67 settimane
|
Fino a circa 67 settimane
|
|
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Event-free Survival (EFS) as assessed by Investigator
Lasso di tempo: At least 2 years
|
EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause. |
At least 2 years
|
|
Disease-free Survival (DFS) as assessed by Investigator
Lasso di tempo: At least 2 years
|
DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death due to any cause. |
At least 2 years
|
|
Distant Disease-free Survival (DDFS) as assessed by Investigator
Lasso di tempo: At least 2 years
|
DDFS is defined as the time from surgery to distant recurrence, or death due to any cause. |
At least 2 years
|
|
Objective response rate (ORR) in accordance with RECIST v1.1
Lasso di tempo: Up to approximately 24 weeks
|
Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI. |
Up to approximately 24 weeks
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BCTOP-T-N01
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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