Dose Dense TC + Pegfilgrastim Support for Breast Cancer

NCT01671319 | Completed Phase 2 Results DMC

• 5 other identifiers: CO101042011-0062NCI-2011-03640A535900SMPH\ONCOLOGY\ONCOLOGY
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Female Breast Cancer

Keywords

breast cancer; female; women; adjuvant

Outcome Measures

Primary Outcomes (1)

• Feasibility for Dose-dense TC Therapy: Number of Participants Receiving at Least 90% of Total Dose of Therapy

  Evaluate 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. Feasibility defined by at least 60% of patients receiving 90% of the total dose of therapy within 10 weeks.

  4 cycles each 2 weeks in length for a total of 8 weeks, up to 10 weeks

Secondary Outcomes (2)

• Incidence of Febrile Neutropenia

  Up to 10 weeks

• Incidence of Neuropathy

  Up to 10 weeks

Study Arms (1)

dose dense TC + pegfilgrastim

EXPERIMENTAL

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

Interventions

docetaxel + cyclophosphamide + pegfilgrastim DRUG

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

Also known as: Taxotere, Cytoxan, Neulasta

dose dense TC + pegfilgrastim

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Amgen: collaborator

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Burkard ME, Wisinski KB, Njiaju UO, Donohue S, Hegeman R, Stella A, Mansky P, Shah V, Goggins T, Qamar R, Dietrich L, Kim K, Traynor AM, Tevaarwerk AJ. Feasibility of 4 cycles of docetaxel and cyclophosphamide every 14 days as an adjuvant regimen for breast cancer: a Wisconsin Oncology Network study. Clin Breast Cancer. 2014 Jun;14(3):205-11. doi: 10.1016/j.clbc.2013.10.018. Epub 2013 Oct 26.

  PMID: 24342730 RESULT

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Cyclophosphamide; pegfilgrastim

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; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Dr. Amyé Tevaarwerk
• Organization: University of Wisconsin Carbone Cancer Center

at4@medicine.wisc.edu

608-262-2837

Study Officials

• Amye J Tevaarwerk, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 23, 2012
• Study Start: June 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 27, 2019
• Results First Posted: October 12, 2017

Record last verified: 2017-09

Locations

US (1)