A Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy With Doxorubicin (A)/Cyclophosphamide ©) and/or Weekly Paclitaxel

NCT00131963 | Completed

• 3 other identifiers: Pro00014267DUMC-4522-04-1-R1CDR0000438673
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well doxorubicin, cyclophosphamide, and/or paclitaxel work in treating women with nonmetastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage One A (IA) breast cancer; stage Two (II) breast cancer; stage Three A (IIIA) breast cancer; stage Three B(IIIB) breast cancer; stage Three C(IIIC) breast cancer; stage One B (IB) breast cancer

Outcome Measures

Primary Outcomes (2)

• Treatment-induced myelosuppression (e.g., neutropenia)

  12 months

• Incidence of peripheral neuropathy

  12 month

Secondary Outcomes (1)

• Response (relapse in adjuvant setting) for 10 years after completion of study treatment

  Ten years

Study Arms (2)

Regimen 1

Patients receive doxorubicin IV over 10 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.

Drug: cyclophosphamide; Drug: doxorubicin

Regimen 2

Patients receive doxorubicin and cyclophosphamide as in regimen 1. Patients then receive paclitaxel IV over 1 hour once weekly for 12 weeks.

Drug: cyclophosphamide; Drug: doxorubicin; Drug: paclitaxel

Interventions

cyclophosphamide DRUG

Given IV

Also known as: Cytoxan

Regimen 1; Regimen 2

doxorubicin DRUG

Given IV

Also known as: adriamycin

Regimen 1; Regimen 2

paclitaxel DRUG

Given IV

Also known as: taxol

Regimen 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be recruited from the breast cancer oncology clinics.

You may not qualify if:

• Other anticancer cytotoxic or endocrine therapy, immunotherapy, or biologic response modifiers,Study Drugs or other concomitant medications known to cause myelosuppression especially neutropenia and neuropathy
• Eastern Cooperative Oncology Group Performance Status(ECOG) functional status \> 2.
• Serious co-morbidities including poorly controlled diabetes mellitus, ischaemic heart disease,uncontrolled hypertension or active infection.
• Pregnancy
• Use of growth factor during cycle 1 of chemotherapy (AC) under pharmacokinetic evaluation
• Grade \>/=2 peripheral neuropathy symptoms based on National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) Scale. Exception: a chronic neurologic disorder will be reviewed on a case by case basis by the study PI.
• Prior treatment with weekly paclitaxelDISEASE CHARACTERISTICS:
• Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:
• Node negative disease AND meets 1 of the following stage criteria:
• Primary tumor \> T1c
• Primary tumor \> T1b AND poor prognostic features, defined as the following:
• High-grade disease
• Human Epidermal Growth Factor Receptor 2 (HER2)/neu-positive disease by fluorescence in situ hybridization
• Estrogen receptor-negative disease
• Stage II disease (T2, N0)

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be extracted from blood samples taken at the first cycle of Doxorubicin and/or Paclitaxel to analyze certain genes that may predict the severity of side-effects that may be experienced with chemotherapy.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Doxorubicin; Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Paul K. Marcom, MD

  Duke Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2005
• First Posted: August 19, 2005
• Study Start: October 1, 2003
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 25, 2016

Record last verified: 2015-11

Locations

US (1)