Clinical trial · Interventional
Preoperative Cisplatin in Early Stage Breast Cancer
A Phase II Trial of Cisplatin in Early Stage ER-, PR-, HER-2 Negative Breast Cancer
NCT00148694CI-TRIAL-00023724completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out what effects the preoperative therapy cisplatin will have on patients with early stage estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), or HER-2 negative breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention single arm
- description
- Cisplatin 75mg/m2 q21 days x 4 pre-surgery
- interventionNames
- Drug: Cisplatin
Primary outcomes (1)
- measure
- To determine the clinical response after preoperative therapy with cisplatin in ER-, PR-, HER-2 negative early breast cancer patients
Secondary outcomes (1)
- measure
- To determine the pathologic complete response after preoperative therapy with cisplatin in this patient population
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTSilver 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. PMID 20100965
- RESULTBirkbak 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. PMID 22576213