Dose Dense TC + Pegfilgrastim Support for Breast Cancer (ddTC)

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01671319
First received: August 5, 2011
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine the feasibility of giving standard TC chemotherapy on a dose dense schedule (ddTC) as well as evaluating the nature and frequency of ddTC side effects.


Condition Intervention Phase
Female Breast Cancer
Drug: docetaxel + cyclophosphamide + pegfilgrastim
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Dose-Dense TC (Docetaxel + Cyclophosphamide) With Pegfilgrastim Support for Adjuvant Therapy of pN0, pN1 or Nx Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Tolerability and Feasibility for dose dense schedule [ Time Frame: 4 cycles each 2 weeks in length for a total of 8 weeks ] [ Designated as safety issue: No ]
    Evaluate the tolerability and feasibility of delivering 4 cycles (1 cycle = 2 weeks) of docetaxel and cyclophosphamide (TC) on a dose-dense (q2week) schedule with pegfilgrastim support. This regimen will be referred to as dose-dense (dd)TC.


Enrollment: 41
Study Start Date: June 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dose dense TC + pegfilgrastim
Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle
Drug: docetaxel + cyclophosphamide + pegfilgrastim
docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle
Other Name: Taxotere, Cytoxan, Neulasta

Detailed Description:

A standard chemotherapy treatment option for breast cancer after surgery (adjuvant therapy) is docetaxel + cyclophosphamide (TC). This study looks at a different schedule for giving the same adjuvant chemotherapy so that treatment can be completed faster (in 8 weeks rather than 12 weeks). This study uses a growth factor drug, pegfilgrastim, to help build blood cells that are lowered because of chemotherapy, making it possible to receive TC treatment every 2 weeks (referred to as "dose dense TC" or "ddTC") instead of the standard 3 week schedule. The main study procedures are blood draws, chemotherapy treatment, physical exams, and pegfilgrastim injections.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed invasive carcinoma of the female breast, status post definitive surgery (lumpectomy or mastectomy plus nodal evaluation if feasible). Patients must initiate therapy with ddTC within 84 days of the last breast or axillary surgery performed for curative intent
  • candidate for chemotherapy by the treating oncologist
  • Patients with pN2 or pN3 disease are NOT explicitly excluded. However, patients with N2 or N3 disease MUST be reviewed with the PI or study chair before being enrolled on the study as TC would not normally be considered adequate therapy for such patients.
  • Patients with bilateral, synchronous invasive breast cancer are eligible as long as both primary tumors meet the eligibility criteria.
  • Patients with estrogen-receptor (ER) and/or progesterone receptor (PR) negative, positive, or unknown tumors are eligible.
  • Patients with HER2 positive, negative or unknown disease are eligible for this trial. Patients whose tumors are HER2 positive by either immunohistochemistry (IHC) 3+ staining or demonstrate gene amplification by FISH should receive trastuzumab, following completion of adjuvant cytotoxic therapy with 4 cycles of ddTC.
  • There must be negative surgical margins for invasive cancer and DCIS. LCIS is acceptable at the margin.
  • Patients with multi-centric breast cancer are eligible as long as all known disease is resected from the breast with negative margins.
  • Age >18 years.
  • ECOG performance status ≤ 1
  • Women of childbearing potential should have a negative urine or blood beta-HCG, and must agree to contraception if engaging in sexual activity. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women must not be pregnant or nursing as the chemotherapy drugs used in this study may cause harm to a fetus or newborn.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Platelets >/=100,000/μl within 4 weeks of registration.
  • Absolute neutrophil count (ANC) >/= 1,500/μl within 4 weeks of registration.
  • Total bilirubin within normal institutional limits within 4 weeks of registration.
  • Alkaline phosphatase (alk phos) ≤ 2.5 X institutional Upper Limit of Normal (ULN) within 4 weeks of registration.
  • AST (SGOT)/ALT(SGPT) ≤ 1.5X ULN
  • Creatinine within normal institutional limits OR Creatinine clearance>/= 60 mL/min/1.73 m2 for patients with creatinine levels above normal
  • If patient has received tamoxifen or another selective estrogen receptor modulator (SERM) for prevention or for other indications (not for treatment of this cancer), they have been discontinued prior to enrollment.

Exclusion Criteria:

  • Patient has received previous trastuzumab, chemotherapy, hormonal therapy, or other anti-cancer agents (including investigational agents) for this malignancy.
  • Patient will be receiving GNRH agonists such as goserelin (Zoladex) or leuprolide acetate (Lupron) concomitantly with chemotherapy for the purpose of preventing breast cancer recurrence.
  • Patient has inflammatory breast cancer (pT4d) or metastatic breast cancer.
  • Patient has 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.
  • Patient has pre-existing persistent neuropathy.
  • The patient has received prior chemotherapy or radiotherapy or any malignancy within the past 2 years.
  • Patient has received prior docetaxel or cyclophosphamide within the past 5 years.
  • Patient has known contraindication or hypersensitivity to docetaxel, cyclophosphamide or pegfilgrastim.
  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: NCT01671319

Locations
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Amgen
Investigators
Principal Investigator: Amye J Tevaarwerk, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01671319     History of Changes
Other Study ID Numbers: CO10104
Study First Received: August 5, 2011
Last Updated: July 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
breast cancer
female
women
adjuvant

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

ClinicalTrials.gov processed this record on October 23, 2014