- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00191789
Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer
Neoadjuvant Administration of Gemcitabine Plus Doxorubicin Followed by Gemcitabine Plus Cisplatin in Large or Locally Advanced Operable Breast Cancer: A Phase II Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
-
Delhi, India, 110029
- For additional information regarding investigative sites for this clinical trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT -5 hours, EST), or speak with your personal physician.
-
-
Maharashtra
-
Pune, Maharashtra, India, 411001
- For additional information regarding investigative sites for this clinical trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT -5 hours, EST), or speak with your personal physician.
-
-
Tamil Nadu
-
Vellore, Tamil Nadu, India, 632004
- For additional information regarding investigative sites for this clinical trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT -5 hours, EST), or speak with your personal physician.
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Diagnosis of breast carcinoma
- No previous chemotherapy, with bidimensionally measurable locally advanced disease
- Adequate performance status (Karnofsky Performance Status [KPS] greater than or equal to 70), bone marrow reserves, hepatic, cardiac and renal functions.
Exclusion Criteria:
- Inflammatory breast cancer
- Pregnancy and Breast-feeding
- Serious concomitant disorder or infection
- Previous cancer within the last 5 years or a second primary malignancy.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Gemcitabine+Doxorubicin+Cisplatin+Surgery
Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8). Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision. |
1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8)
Altri nomi:
60 mg/m^2, IV, every 21 days x 4 cycles (1-4)
70 mg/m^2, IV, every 21 days x 4 cycles (5-8)
Surgery follows 8 cycles of chemotherapy.
Extent and type of surgery is guided by tumor size, physician and/or patient decision.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)
Lasso di tempo: tumor assessment at baseline and during surgery after eight 21-day treatment cycles
|
Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer.
Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells.
Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified.
|
tumor assessment at baseline and during surgery after eight 21-day treatment cycles
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Summary of Deaths During Study
Lasso di tempo: baseline through last cycle on study drug (eight 21-day cycles)
|
baseline through last cycle on study drug (eight 21-day cycles)
|
|
Progression Free Survival (PFS)
Lasso di tempo: baseline to measured progressive disease or death from any cause (up to 68 months)
|
PFS was defined as the date of enrollment to the first date of documented disease progression or death from any cause.
Because the median was not reached, results are presented as the Outcome: Number of Participants with Disease Progression or Death at Various Timepoints.
|
baseline to measured progressive disease or death from any cause (up to 68 months)
|
Overall Survival
Lasso di tempo: baseline to date of death from any cause up to 68 months
|
Overall survival was defined as the date of enrollment to the date of death from any cause.
Because the median was not reached, results will be presented as the Outcome: Number of Participants who Died from Any Cause at Various Timepoints.
|
baseline to date of death from any cause up to 68 months
|
Time to Treatment Failure
Lasso di tempo: baseline to stopping treatment (up to 68 months)
|
Time to treatment failure was defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment.
Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
Because the upper limit of the 95% Confidence Interval of median survival was not calculable, results are presented as the Outcome: Number of Participants with Time to Treatment Failure at Various Timepoints.
|
baseline to stopping treatment (up to 68 months)
|
Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery
Lasso di tempo: baseline, after eight 21-day cycles of study drug
|
The extent and type of surgery was guided by the tumor size, physician and/or patient decision.
It was either conservation surgery or mastectomy with axillary lymph node dissection.
Results are reported on the number of patients who underwent breast conservation surgery.
|
baseline, after eight 21-day cycles of study drug
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT -5 hours, EST), Eli Lilly and Company
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie della pelle
- Neoplasie
- Neoplasie per sede
- Malattie del seno
- Neoplasie mammarie
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Agenti antivirali
- Inibitori enzimatici
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Inibitori della topoisomerasi II
- Inibitori della topoisomerasi
- Antibiotici, Antineoplastici
- Gemcitabina
- Doxorubicina
Altri numeri di identificazione dello studio
- 7117
- B9E-MC-S329 (Altro identificatore: Eli Lilly and Company)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cancro al seno
-
Emory UniversityNational Cancer Institute (NCI)RitiratoCancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nel cervello | Carcinoma mammario metastatico | Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8
-
NRG OncologyNational Cancer Institute (NCI)Attivo, non reclutanteCancro al seno in stadio anatomico IV AJCC v8 | Cancro al seno in stadio IV prognostico AJCC v8 | Neoplasia maligna metastatica nell'osso | Neoplasia maligna metastatica nei linfonodi | Neoplasia maligna metastatica nel fegato | Carcinoma mammario metastatico | Neoplasia maligna metastatica nel... e altre condizioniStati Uniti, Canada, Arabia Saudita, Corea, Repubblica di
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University e altri collaboratoriCompletatoLa guida all'applicazione clinica di Conebeam Breast CTCina
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletatoAdenocarcinoma dell'intestino tenue | Adenocarcinoma dell'intestino tenue in stadio III AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIA AJCC v8 | Adenocarcinoma dell'intestino tenue in stadio IIIB AJCC v8 | Adenocarcinoma dell'intestino tenue stadio IV AJCC v8 | Ampolla di Vater... e altre condizioniStati Uniti
-
Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...CompletatoStudio delle donne cinesi che non hanno aderito alle linee guida per lo screening mammografico dell'American Cancer SocietyStati Uniti
-
National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
-
Novartis PharmaceuticalsReclutamentoEGFR mutante avanzato Non SmallSellLung Cancer (NSCLC), KRAS G12-mutant NSCLC, Esophageal SquamousCell Cancer (SCC), Head/Neck SCC, MelanomaOlanda, Corea, Repubblica di, Spagna, Taiwan, Giappone, Italia, Stati Uniti, Singapore, Canada
-
Rashmi Verma, MDNational Cancer Institute (NCI)ReclutamentoCarcinoma prostatico resistente alla castrazione | Adenocarcinoma prostatico metastatico | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Jonsson Comprehensive Cancer CenterNon ancora reclutamentoCarcinoma della prostata | Stadio IVB Cancro alla prostata American Joint Committee on Cancer (AJCC) v8Stati Uniti
-
Assiut UniversityNon ancora reclutamentoDeterminare l’incidenza cumulativa di AKI utilizzando i criteri KDIGO in pazienti pediatrici con tumori maligni presso il South Egypt Cancer Institute (SECI)