Triciribine Phosphate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide in Treating Patients With Stage IIB-IV Breast Cancer

Description

The investigators hypothesize that the addition of a specific AKT inhibitor (triciribine) to the regimen of weekly paclitaxel (followed sequentially by AC) will enhance the pathologic complete response rate in patients with locally advanced breast cancer.

Study Start Date

January 2012

Estimated Completion Date

January 2018

Interventions

  • Drug: Paclitaxel
  • Drug: Doxorubicin
  • Drug: Triciribine Phosphate
  • Drug: Doxorubicin Hydrochloride
  • Other: Laboratory Biomarker Analysis
  • Drug: Triciribine
  • Drug: triciribine phosphate
  • Drug: Cyclophosphamide
  • Procedure: Therapeutic Conventional Surgery
  • Drug: paclitaxel
  • Procedure: therapeutic conventional surgery
  • Other: laboratory biomarker analysis
  • Drug: doxorubicin hydrochloride
  • Drug: cyclophosphamide

Specialties

  • Obstetrics & Gynecology: Breast,Clinical Pharmacology
  • Oncology: Breast,Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology,Drug Trials

MeSH Terms

  • Breast Neoplasms

Study ID

Albert Einstein College of Medicine of Yeshiva University -- 2011-269

Status

Unknown

Trial ID

NCT01697293

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

56

Sponsor

Albert Einstein College of Medicine of Yeshiva University

Inclusion Criteria

  • Phase I: Patients must have histologically or cytologically confirmed adenocarcinoma of the breast associated with the following clinical stage: clinical IIIC or IV .The tumor must be Her2/neu negative
  • Phase II: Patients must have histologically or cytologically confirmed adenocarcinoma of the breast associated with the following clinical stage: IIB, IIIA, IIIB, or IIIC.The tumor must be Her2/neu negative
  • Phase I: Up to two prior non-taxane chemotherapy regimens for metastatic disease is permitted for patients enrolled on the phase I portion.
  • Phase II: No prior chemotherapy, irradiation, or definitive therapeutic surgery for this malignancy. Patients who have had a prior sentinel lymph node biopsy for this malignancy are eligible.
  • Patients who received tamoxifen or another selective estrogen receptor modulator (SERM) for prevention or treatment of breast cancer or for other indications (e.g., osteoporosis, prior DCIS), or who receive aromatase inhibitors for prevention or treatment of breast cancer, are eligible. Patients who are hormone-receptor positive and who have received other hormonal agents for the treatment of breast cancer (eg, Fulvestrant) are also eligible.
  • Age >18 years.
  • ECOG performance status 0 or 1.
  • Patients must have normal organ and marrow function as defined below within 2 weeks of registration (except where specified otherwise):
  • leukocytes >3,000/?l
  • absolute neutrophil count >1,500/?l
  • platelets >100,000/?l
  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
  • left ventricular ejection fraction within normal institutional limits
  • creatinine within normal institutional limits
  • left ventricular ejection fraction at or above institutional lower limits of normal (by echocardiogram or nuclear scan within 12 weeks of registration for patients treated in the phase II portion of the trial who will receive AC chemotherapy)
  • EKG QTc < 450 msec
  • serum calcium & phosphorus within normal institutional limits
  • Hemoglobin A1C Patients must be disease-free of prior invasive malignancies for > 2 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix. Patient with the following prior or concurrent diagnoses are eligible: lobular carcinoma in situ, contralateral ductal carcinoma in situ, or contralateral invasive ductal and/or lobular cancer (an no prior adjuvant chemotherapy for previous breast malignancy).
  • Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation due to the unknown effects.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

  • Patients may not be receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to triciribine or other agents used in the study (e.g., imidazoles, quinolones)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes mellitus requiring therapy (insulin or oral hypoglycemic agents), congenital prolonged QT syndrome, requirement for a drug known to prolong the QT interval, a history of QT prolongation, a screening QTc >/= 450 msec, hypertriglyceridemia requiring therapy, 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
  • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with triciribine or other agents administered during the study.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (3)

Study Location Distance Name Phone Email
Albert Einstein College of Medicine - Bronx, New York 40.3 miles None None None
Moffitt Cancer Center - Tampa, Florida 1,050.4 miles Hyo S Han 813-745-8480 hyo.han@moffitt.org
Moffitt Cancer Center - Tampa, Florida 1,050.4 miles None None None

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.