Clinical trial · Interventional
A Study of Gemcitabine, Epirubicin, and Paclitaxel Combination Chemotherapy Given Before Surgery to Patients With Locally Advanced Breast Cancer
A Phase 2 Study of Neoadjuvant Chemotherapy With Gemcitabine, Epirubicin and Paclitaxel (Taxol)[GET] in Locally Advanced Breast Cancer
NCT00378313CI-TRIAL-00001812completedPhase 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 primary purpose of this study is to determine whether locally advanced breast cancer responds (by shrinking, by not progressing or by being destroyed) to combined chemotherapy (gemcitabine, epirubicin and paclitaxel) given before surgery to patients with locally advanced breast cancer. This study will also evaluate the toxicity of the chemotherapy combination to patients and will determine survival and progression-free survival 2 years after treatment. Also, the study will look at whether there are molecular and genetic changes in the tumor tissue that match the tumor's response to the chemotherapy.
Conditions
Conditions (6)
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 |
| Locally Advanced | — | UNRESOLVED | — |
| Stage IIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine, epirubicin, paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the pathological response rate in tumors of patients with locally advanced breast cancer who receive 4 to 6 cycles of GET chemotherapy
Secondary outcomes (3)
- measure
- To determine the clinical response rate
- measure
- to evaluate the toxicity of the GET combination
- measure
- to determine feasibility of tissue collection and analysis of potential molecular and genetic correlates of response; to determine the 2-year survival and 2-year progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Females only * Consent for the collection of biopsy tissue in RNAlater solution * Biopsy specimens that were obtained by core biopsy or incisional biopsy and placed in RNAlater solution * Breast cancer that is: * unilateral * diagnosed histologically as invasive breast cancer without evidence of metastatic disease (except for stage IV with positive supraclavicular nodes only) * stage IIB, IIIA (T0-3N2), IIIB (T4N0-3 or T0-3N3), or IV (by involvement of positive supraclavicular nodes only). (Patients with clinical evidence of inflammatory breast cancer or superficial lesions must have a measurable mass in the breast or lymph nodes.) * measurable by physical exam, mammography, sonogram, CT scan, MRI, or x-ray * Evidence of adequate organ function (liver, bone marrow, kidney) * Ability to perform an adequate level of physical activity (Zubrod scale 0, 1, or 2) * Life expectancy of at least 10 years * Childbearing potential terminated by surgery, radiation, or menopause, or attenuated by use of an effective non-hormonal, barrier contraceptive method * Disease-free from prior nonbreast malignancies for at least 5 years before entry * Adequate cardiac function( measured by baseline LVEF on MUGA or echocardiogram greater than or equal to the institution's lower limit of normal) Exclusion criteria: * Male * Hormonal birth control * The use of hormonal agents or raloxifene * Active infection * Pregnancy or breastfeeding * Bilateral malignancy or a mass in the opposite breast suspicious for malignancy, unless there is biopsy proof that the mass is not malignant * Previous therapy for breast cancer * Nonmalignant systemic disease that would keep the patient from being given the treatment or would prevent long-term follow-up * Active cardiac disease that would preclude the use of epirubicin and/or Taxol * Significant abnormal peripheral nerve disease (greater than or equal to Grade 2) * Any prior anthracycline or taxane-containing chemotherapy * Use of any investigational agent within one month before enrollment * Excisional biopsy of the breast
References
Publications (1)
- RESULTHamm JT, Wilson JW, Rastogi P, Lembersky BC, Tseng GC, Song YK, Kim W, Robidoux A, Raymond JM, Kardinal CG, Shalaby IA, Ansari R, Paik S, Geyer CE, Wolmark N; NSABP Foundation Research Group. Gemcitabine/epirubicin/paclitaxel as neoadjuvant chemotherapy in locally advanced breast cancer: a phase II trial of the NSABP Foundation Research Group. Clin Breast Cancer. 2008 Jun;8(3):257-63. doi: 10.3816/CBC.2008.n.029. PMID 18650156