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Breast CancerPhase 1/2NCT00066443

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

A Phase 1/2 study testing pegfilgrastim, docetaxel and epirubicin hydrochloride in people with Breast Cancer, run by NCIC Clinical Trials Group at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
pegfilgrastim, docetaxel and epirubicin hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
5 sitesCanada
Study dates
3 Nov 2003to 16 Jan 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • CHA-Hopital Du St-Sacrement

    Québec, Quebec, G1S 4L8

  • Atlantic Health Sciences Corporation

    Saint John, New Brunswick, E2L 4L2

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: A Phase I/II Study Of Increasing Doses Of Epirubicin And Docetaxel Plus Pegfilgrastim For Locally Advanced Or Inflammatory Breast Cancer

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.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose and recommended phase II dose of docetaxel and epirubicin when given with pegfilgrastim in women with locally advanced or inflammatory breast cancer. (Phase I, group 1 closed to accrual as of 9/13/04 and Phase II, group 1 closed to accrual as of 5/10/06)
  • Determine the toxicity of this regimen in these patients.
  • Determine the clinical and pathological response rate and duration of response in patients treated with this regimen.
  • Determine drug sensitivity and resistance in patients treated with this regimen.
  • Determine prognostic and predictive markers in patients treated with this regimen.

OUTLINE: This is a nonrandomized, multicenter, dose-escalation study of docetaxel and epirubicin.

  • Phase I:

Group 1 (21-day regimen) (closed to accrual as of 09/13/04): Patients receive epirubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with objective response after 6 courses may receive additional therapy at the discretion of the physician.

Group 2 (14-day regimen): Patients receive epirubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients with objective response after 8 courses may receive additional therapy at the discretion of the physician.

Cohorts of 3-6 patients receive escalating doses of epirubicin and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II:

Group 1 (21-day regimen) (closed to accrual as of 5/10/06): Patients receive treatment as in phase I with epirubicin and docetaxel at the recommended Phase II dose.

Group 2 (14-day regimen): Patients receive treatment as in phase I with epirubicin and docetaxel at the recommended Phase II dose.

Patients are followed at 1 month, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 90 patients will be accrued for this study.

Conditions
Breast Cancer
Being tested
pegfilgrastim, docetaxel, epirubicin hydrochloride
Keywords
stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, inflammatory breast cancer
Medical subject headings
Breast Neoplasms, Inflammatory Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pegfilgrastimBiological

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

  • docetaxelDrug

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

  • epirubicin hydrochlorideDrug

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

Study groups in NCT00066443
Study groupRoleWhat they receive
Pegfilgrastim, docetaxel and epirubicinExperimentalNot described
Receives: Biological: pegfilgrastim; Drug: docetaxel; Drug: epirubicin hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxic effects

    Findings were presented at ASCO 2010

    Measured: 7 years

  2. Response (phase II)

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

    Measured: 12 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2003 (estimated)
  2. Study start3 Nov 2003
  3. Primary completion6 Jan 2010
  4. Study completion16 Jan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00066443
Sponsor's protocol ID
MA22
Other IDs
CAN-NCIC-MA22, CDR0000316237
Status last verified
Mar 2020
First submitted
6 Aug 2003
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19771508

  • 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.

    PubMed 26543765

  • 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.

    PubMed 26208483

  • 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.

    PubMed 26063893

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing pegfilgrastim, docetaxel and epirubicin hydrochloride in people with Breast Cancer, run by NCIC Clinical Trials Group at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxic effects (time frame: 7 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00066443, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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