Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer

NCT00066443 | Completed Phase 1 DMC

• 3 other identifiers: MA22CAN-NCIC-MA22CDR0000316237
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 5

Brief Summary

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

Breast Cancer

Keywords

stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; inflammatory breast cancer

Outcome Measures

Primary Outcomes (2)

• Toxic effects

  Findings were presented at ASCO 2010

  7 years

• Response (phase II)

  Response was presented at ASCO 2010. Duration of response will be analyzed in 2015

  12 years

Study Arms (1)

Pegfilgrastim, docetaxel and epirubicin

EXPERIMENTAL

Biological: pegfilgrastim; Drug: docetaxel; Drug: epirubicin hydrochloride

Interventions

pegfilgrastim BIOLOGICAL

Dose escalation schedule A\&B = 6mg fixed dose once per cycle on day 2

Pegfilgrastim, docetaxel and epirubicin

docetaxel DRUG

Dose Escalation schedule A = 75-85 mg/m2 Dose Escalation schedule B = 50-75 mg/m2

Pegfilgrastim, docetaxel and epirubicin

epirubicin hydrochloride DRUG

Dose escalation schedule A = 75-120 mg/m2 IV Dose escalation schedule B = 50-90 mg/m2 IV

Pegfilgrastim, docetaxel and epirubicin

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (5)

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Atlantic Health Sciences Corporation

Saint John, New Brunswick, E2L 4L2, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHA-Hopital Du St-Sacrement

Québec, Quebec, G1S 4L8, Canada

Location

Related Publications (4)

• Parissenti 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 RESULT

• Trudeau 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 RESULT

• Parissenti 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 DERIVED

• Pritzker 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms

Interventions

pegfilgrastim; Docetaxel; Epirubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Maureen E. Trudeau, BSc, MA, MD, FRCPC

  Toronto Sunnybrook Regional Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Start: November 3, 2003
• Primary Completion: January 6, 2010
• Study Completion: January 16, 2014
• Last Updated: March 27, 2026

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)