- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00148694
Preoperative Cisplatin in Early Stage Breast Cancer
A Phase II Trial of Cisplatin in Early Stage ER-, PR-, HER-2 Negative Breast Cancer
Studieoversigt
Detaljeret beskrivelse
Before starting treatment patients will undergo placement of a clip into the tumor bed so the surgeon can locate the site of the tumor at the time of surgery.
Patients will receive cisplatin intravenously once every three weeks for a total of 4 cycles or 12 weeks of treatment.
After completion of cisplatin, patients will undergo surgery to remove any tumor that remains and to assess the tissue to see if tumor cells remain in the breast.
Patients may receive a second breast MRI and biopsy 7-14 days after treatment begins to see whether we can identify tumors that will ultimately respond to cisplatin with a rapid evaluation.
Patients will receive study treatment for approximately 12 weeks unless unacceptable toxicity occurs. After surgery patients will receive standard adjuvant therapy based on discussion with their physician. Follow-up progress will occur for several years.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Forenede Stater, 02115
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Forenede Stater, 02115
- Massachusetts General Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- All tumors must be ER-, PR- and HER-2 negative.
- Age > 18 years
- ECOG performance status of less than or equal to 1
- Absolute neutrophil count (ANC) > 1,500/mm3
- Hemoglobin > 9mm/dl
- Platelets > 100,000/mm3
- Creatinine < 1.5mg/dl
- Glucose < 200mg/dl
- Bilirubin < 1.5 x upper limit of normal (ULN)
- SGOT < 3.0 x ULN
Exclusion Criteria:
- Prior chemotherapy treatment
- Pregnant or breast-feeding women
- History of serious illness, medical or psychiatric condition requiring medical management
- Uncontrolled infection
- Renal dysfunction
- Active or severe cardiovascular or pulmonary disease
- Peripheral neuropathy of any etiology that exceeds grade 1
- Prior history of malignancy
- Uncontrolled diabetes
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Intervention single arm
Cisplatin 75mg/m2 q21 days x 4 pre-surgery
|
Intravenously once every three weeks for a total of 12 weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
To determine the clinical response after preoperative therapy with cisplatin in ER-, PR-, HER-2 negative early breast cancer patients
|
Sekundære resultatmål
Resultatmål |
---|
To determine the pathologic complete response after preoperative therapy with cisplatin in this patient population
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Judy E. Garber, MD, Dana-Farber Cancer Institute
Publikationer og nyttige links
Generelle publikationer
- Silver DP, Richardson AL, Eklund AC, Wang ZC, Szallasi Z, Li Q, Juul N, Leong CO, Calogrias D, Buraimoh A, Fatima A, Gelman RS, Ryan PD, Tung NM, De Nicolo A, Ganesan S, Miron A, Colin C, Sgroi DC, Ellisen LW, Winer EP, Garber JE. Efficacy of neoadjuvant Cisplatin in triple-negative breast cancer. J Clin Oncol. 2010 Mar 1;28(7):1145-53. doi: 10.1200/JCO.2009.22.4725. Epub 2010 Jan 25.
- Birkbak NJ, Wang ZC, Kim JY, Eklund AC, Li Q, Tian R, Bowman-Colin C, Li Y, Greene-Colozzi A, Iglehart JD, Tung N, Ryan PD, Garber JE, Silver DP, Szallasi Z, Richardson AL. Telomeric allelic imbalance indicates defective DNA repair and sensitivity to DNA-damaging agents. Cancer Discov. 2012 Apr;2(4):366-375. doi: 10.1158/2159-8290.CD-11-0206. Epub 2012 Mar 22. Erratum In: Cancer Discov. 2013 Aug;3(8):952.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 04-183
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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