Clinical trial · Interventional
Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer
A Phase I/II Study Of Increasing Doses Of Epirubicin And Docetaxel Plus Pegfilgrastim For Locally Advanced Or Inflammatory Breast Cancer
NCT00066443CI-TRIAL-00106536completedPhase 1 / Phase 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)
RATIONALE: Drugs used in chemotherapy such as epirubicin and docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin and docetaxel with pegfilgrastim in treating women who have locally advanced or inflammatory 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pegfilgrastim, docetaxel and epirubicin
- interventionNames
- Biological: pegfilgrastim
- Drug: docetaxel
- Drug: epirubicin hydrochloride
Primary outcomes (2)
- measure
- Toxic effects
- timeFrame
- 7 years
- description
- Findings were presented at ASCO 2010
- measure
- Response (phase II)
- timeFrame
- 12 years
- description
- Response was presented at ASCO 2010. Duration of response will be analyzed in 2015
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed invasive adenocarcinoma of the breast, meeting any of the following criteria: * T4, NX, M0 * Any T, N2-N3, M0 * Inflammatory breast cancer (redness over at least one-third of the breast), M0 * No evidence of metastatic disease by chest x-ray, abdominal ultrasound or CT scan and bone scan * Diagnosed within the past 8 weeks * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 16 and over Sex * Female Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin less than upper limit of normal (ULN) * Must meet criteria for 1 of the following: * ALT and AST no greater than 1.5 times ULN AND alkaline phosphatase no greater than 2.5 times ULN * ALT and AST normal AND alkaline phosphatase no greater than 5 times ULN Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * Resting LVEF normal by MUGA or echocardiogram * No congestive heart failure * No angina pectoris * No myocardial infarction within the past year * No uncontrolled hypertension * No uncontrolled arrhythmias Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective non-hormonal contraception * No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * No symptomatic peripheral neuropathy grade 2 or greater * No active infection * No history of significant neurological or psychiatric disorders, including dementia or seizures * No peptic ulcer * No unstable diabetes mellitus * No contraindication to dexamethasone * No known sensitivity to E. coli-derived or polyethylene glycol products * Willing to undergo core biopsies once prior to registration and core biopsies at 2 other timepoints while on study * Geographically accessible for treatment and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy for breast cancer Chemotherapy * No prior chemotherapy for breast cancer Endocrine therapy * No prior hormonal therapy for breast cancer * No concurrent corticosteroids except for premedication or hypersensitivity reaction * No concurrent oral contraception Radiotherapy * No prior radiotherapy for breast cancer Surgery * No prior surgery for breast cancer other than biopsy Other * No prior systemic therapy for breast cancer * No other concurrent investigational drugs or anticancer treatment * No concurrent preventative IV antibiotics
References
Publications (4)
- RESULTParissenti AM, Chapman JA, Kahn HJ, Guo B, Han L, O'Brien P, Clemons MP, Jong R, Dent R, Fitzgerald B, Pritchard KI, Shepherd LE, Trudeau ME. Association of low tumor RNA integrity with response to chemotherapy in breast cancer patients. Breast Cancer Res Treat. 2010 Jan;119(2):347-56. doi: 10.1007/s10549-009-0531-x. PMID 19771508
- RESULTTrudeau ME, Chapman JA, Guo B, Clemons MJ, Dent RA, Jong RA, Kahn HJ, Pritchard KI, Han L, O'Brien P, Shepherd LE, Parissenti AM. A phase I/II trial of epirubicin and docetaxel in locally advanced breast cancer (LABC) on 2-weekly or 3-weekly schedules: NCIC CTG MA.22. Springerplus. 2015 Oct 21;4:631. doi: 10.1186/s40064-015-1392-x. eCollection 2015. PMID 26543765
- DERIVEDParissenti AM, Guo B, Pritzker LB, Pritzker KP, Wang X, Zhu M, Shepherd LE, Trudeau ME. Tumor RNA disruption predicts survival benefit from breast cancer chemotherapy. Breast Cancer Res Treat. 2015 Aug;153(1):135-44. doi: 10.1007/s10549-015-3498-9. Epub 2015 Jul 25. PMID 26208483
- DERIVEDPritzker K, Pritzker L, Generali D, Bottini A, Cappelletti MR, Guo B, Parissenti A, Trudeau M. RNA Disruption and Drug Response in Breast Cancer Primary Systemic Therapy. J Natl Cancer Inst Monogr. 2015 May;2015(51):76-80. doi: 10.1093/jncimonographs/lgv015. PMID 26063893