Dose Dense TC + Pegfilgrastim Support for Breast Cancer
Condition: Female Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: docetaxel + cyclophosphamide + pegfilgrastim
Intervention description: 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
Intervention MeSH terms: Cyclophosphamide; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; female; women; adjuvant

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.
    

Eligibility 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.