Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Docetaxel

Cyclophosphamide

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle

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

docetaxel + cyclophosphamide + pegfilgrastim

Amye J Tevaarwerk, MD

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.

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.

Dose Dense TC + Pegfilgrastim Support for Breast Cancer

Phase II Study of Dose-Dense TC (Docetaxel + Cyclophosphamide) With Pegfilgrastim Support for Adjuvant Therapy of pN0, pN1 or Nx Breast Cancer

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.

Neutropenic fever was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.

Neuropathy was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.

Amgen

University of Wisconsin, Madison

Toxicity assessments were made one day 1 of each cycle, and as indicated clinically.

Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle

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

Dose Dense TC + Pegfilgrastim

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Premenopausal

Postmenopausal

Pre- vs. Postmenopausal

Node-negative

Node-positive

Nodes unknown

Participants were staged according to the American Joint Committee on Cancer (AJCC) staging manual.

Node-negative: cancer has not spread to the lymph nodes Node-positive: cancer that has spread to the lymph nodes T1 and T2 refer to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues.

Staging Criteria

Hormone receptor-postive

HER2-positive

Triple negative

Receptor Status

Mastectomy

Breast conservation

Final Surgery

Dr. Amyé Tevaarwerk

Of 42 participants, 41 were evaluable for outcome measure analysis.

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

Incidence of Febrile Neutropenia

Incidence of Neuropathy

Overall Study

Spots Global Cancer Trial Database for docetaxel + cyclophosphamide + pegfilgrastim