Study of Neoadjuvant Docetaxel and Cyclophosphamide in Locally Advanced or Node Positive Primary Breast Cancer With Companion Pharmacokinetic and Pharmacogenomic Analyses

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by National Cancer Centre, Singapore.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
National Cancer Centre, Singapore
ClinicalTrials.gov Identifier:
NCT01540110
First received: January 31, 2012
Last updated: February 22, 2012
Last verified: August 2010
  Purpose

Primary

The purpose of this study is to evaluate tumour pathological complete response rate after six cycles of neoadjuvant docetaxel and cyclophosphamide in an Asian population.

Secondary

To assess:

  1. Pharmacokinetics (PK) and pharmacogenomics (PG) of docetaxel cyclophosphamide in Asian patients,
  2. Safety and toxicity of docetaxel cyclophosphamide in Asian patients, and
  3. To determine efficacy of short course (3 days) filgrastim in primary and secondary prophylaxis against febrile neutropenia in patients receiving docetaxel and cyclophosphamide.

Condition Intervention Phase
Breast Cancer
Drug: Neoadjuvant Docetaxel and Cyclophosphamide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Neoadjuvant Docetaxel and Cyclophosphamide in Locally Advanced or Node Positive Primary Breast Cancer With Companion Pharmacokinetic and Pharmacogenomic Analyses

Resource links provided by NLM:


Further study details as provided by National Cancer Centre, Singapore:

Primary Outcome Measures:
  • To evaluate tumour pathological complete response rate after 6 cycles of neoadjuvant docetaxel and cyclophosphamide in Asian population [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate tumour pathological complete response rate after 6 cycles of neoadjuvant docetaxel and cyclophosphamide in Asian population


Estimated Enrollment: 41
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Neoadjuvant Docetaxel and Cyclophosphamide

    5.1.1 Docetaxel Docetaxel at a dose of 75 mg/m2 will be administered by intravenous infusion over 90 minutes (AFTER completion of cyclosphosphamide 600 mg/m2) on D1 every 21 days for 6 cycles using nonpolyvinylchloride tubing.

    Standard premedication with oral dexamethasone 8 mg bd on D-1, D1 and D2 will be administered. Alternatively, intravenous dexamethasone 8 mg before docetaxel followed by oral dexamethasone 8 mg bd on D1 and D2 can be given.

    Routine prevention of chemotherapy induced emesis will be administered (see 5.2.2)

    5.1.2 Cyclophosphamide

    Cyclophosphamide 600 mg/m2 by slow intravenous infusion over 10 minutes (BEFORE docetaxel) will be administered every 21 days for 6 cycles.

    No premedications are required except for routine prevention of chemotherapy induced emesis (see 5.2.2)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically confirmed invasive breast cancer.
  • Patients must have either locally advanced (cT3-T4, N0-3 or cTx, T0-4, N2-N3) or lymph node positive breast cancer
  • Age >21 years. Because no dosing or adverse event data are currently available on the use of docetaxel in patients <21 years of age, children are excluded from this study but will be eligible for future pediatric phase 2 combination trials.
  • Life expectancy of greater than 10 years.
  • ECOG performance status <2 (Karnofsky >60%; see Appendix A).
  • Patients must have normal organ and marrow function as defined below:

    • leukocytes >3,000/mL
    • absolute neutrophil count >1,500/mL
    • platelets >100,000/mL
    • total bilirubin within normal institutional limits
    • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
    • creatinine within normal institutional limits OR
    • creatinine clearance >40 mL/min for patients if creatinine levels above institutional normal
  • The effects of docetaxel on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • HER2 positive breast cancer
  • Metastatic breast cancer
  • Patients who have had any chemotherapy or radiotherapy prior to entering the study.
  • Patients receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel, cyclophosphamide, lenograstim or filgrastim.
  • History of pre-existing peripheral neuropathy
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because chemotherapy in general including docetaxel and cyclophosphamide used in this study are pregnancy class D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued if the mother is treated with chemotherapy. These potential risks may also apply to other agents used in this study.
  • Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with chemotherapy or other agents administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
  • Patients with prior malignancies are excluded except for basal cell carcinoma of the skin and carcinoma in-situ of the cervix who have received curative treatment.
  • Inclusion of Women and Minorities
  • Both men and women of all races and ethnic groups are eligible for this trial.
  • Protocol precautions and restrictions
  • Patients who are pregnant or actively breast feeding are not eligible to participate in this study as stated in 3.2.8. Female patients of child bearing potential will be required to use reliable methods of contraception for the duration of the study and until 4 weeks after the last dose of study treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540110

Locations
Singapore
National Cancer Centre Singapore Recruiting
Singapore, Singapore, 169610
Contact: Wong Nan Soon       ns_wong@source-link.net   
Principal Investigator: Wong Nan Soon         
Sponsors and Collaborators
National Cancer Centre, Singapore
  More Information

No publications provided

Responsible Party: National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT01540110     History of Changes
Other Study ID Numbers: NCC0907
Study First Received: January 31, 2012
Last Updated: February 22, 2012
Health Authority: Singapore: NCCS Clinical Trials Compliance Unit

Keywords provided by National Cancer Centre, Singapore:
Locally Advanced or Node Positive Primary Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 01, 2014