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A Phase I-II Study of Triciribine Phosphate Monohydrate (TCN-PM) Plus Sequential Weekly Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide in Patients With Metastatic and Locally Advanced Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer, Carcinoma Breast Stage IV

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Trial Information

A Phase I-II Study of Triciribine Phosphate Monohydrate (TCN-PM) Plus Sequential Weekly Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide in Patients With Metastatic and Locally Advanced Breast Cancer


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/μl

- absolute neutrophil count >1,500/μl

- platelets >100,000/μl

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended phase II dose of triciribine plus weekly paclitaxel.

Outcome Description:

To determine the recommended phase II dose of triciribine used in combination with weekly paclitaxel.

Outcome Time Frame:

Up to 12 weeks after registration and completion of weekly paclitaxel

Safety Issue:

Yes

Principal Investigator

Joseph Sparano, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Montefiore Medical Center-Weiler Division

Authority:

United States: Food and Drug Administration

Study ID:

2011-269

NCT ID:

NCT01697293

Start Date:

January 2012

Completion Date:

June 2014

Related Keywords:

  • Metastatic Breast Cancer
  • Carcinoma Breast Stage IV
  • Breast
  • Breast Cancer
  • Metastatic Breast Cancer
  • Advanced Breast Cancer
  • Carcinoma Breast Stage IV
  • Carcinoma Breast Stage IIIB
  • TCN-PM
  • Triciribine
  • Breast Diseases
  • Paclitaxel
  • Doxorubicin
  • Cyclophosphamide
  • Triciribine Phosphate Monohydrate
  • Breast Neoplasms
  • Carcinoma

Name

Location

Montefiore Medical Center -Department of Medical OncologyBronx, New York  10461