Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

TERMINATED

RO4929097 and Letrozole in Treating Post-Menopausal Women With Hormone Receptor-Positive Stage II or Stage III Breast Cancer

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Estrogen Receptor-positive Breast Cancer

HER2-negative Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE1

Brief Summary

This phase I trial is studying the side effects and best dose of RO4929097 when given together with letrozole in treating post-menopausal women with stage II or stage III breast cancer. RO4929097 may ...

Detailed Description

PRIMARY OBJECTIVES: I. To establish the maximum-tolerated dose and the recommended phase II dose of gamma-secretase inhibitor RO4929097 (RO4929097) in combination with letrozole in post-menopausal wo...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Pathologically confirmed invasive breast cancer
  • Stage II or III disease (T2-T3, N0-2)
  • No N3, T4 disease
  • Estrogen receptor-positive (ER+) and/or progesterone receptor-positive (PR+)
  • H score ≥ 10 or positivity ≥ 10%
  • HER2 negative as determined by IHC (1 or 2+) or FISH (\< 2.0+)
  • Bilateral disease allowed as long as all tumors are ER+ and ≥ 1 is T2-T3
  • Patient must have disease that is palpable on physical exam and able to be imaged via breast ultrasound
  • Defined as ≥ 1 T2 tumor \> 2 cm
  • Multifocal disease allowed provided that ≥ 1 of the tumors is \> 2 cm
  • No metastatic disease by CT scans of the chest, abdomen, and pelvis, a PET/CT bone scan, or nuclear medicine bone scan
  • No inflammatory breast cancer or presence of breast tumor cells in the dermal lymphatics of the breast
  • Post-menopausal meeting 1 of the following criteria:
  • Bilateral oophorectomy
  • Age ≥ 50 years and amenorrheic for \> 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression (spontaneous amenorrhea)
  • ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)
  • Life expectancy \> 3 months
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Baseline QTcF ≤ 470 msec
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gamma secretase inhibitor RO4929097 or other agents used in the study
  • No malabsorption syndrome or other condition that would interfere with intestinal absorption
  • Able to swallow tablets
  • Not serologically positive for hepatitis A, B, or C, or have a history of liver disease, other forms of hepatitis, or cirrhosis
  • No uncontrolled electrolyte abnormalities including hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia, or hypokalemia despite adequate electrolyte supplementation
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • History of torsades de pointes or other significant cardiac arrhythmia other than chronic, stable atrial fibrillation
  • Psychiatric illness and/or social situations that would limit compliance with study requirements
  • Recovered to \< grade 2 CTCAE toxicities related to prior therapy
  • No prior chemotherapy, hormonal therapy, radiotherapy, or biological therapy for breast cancer
  • Prior treatment for non-melanoma skin cancer or carcinoma in situ of the cervix allowed
  • No prior hormone therapy for ductal carcinoma in situ (DCIS)
  • No other concurrent investigational agents
  • No concurrent medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®)
  • No concurrent medications that are strong inducers and/or inhibitors or substrates of CYP3A4
  • Switching to alternative medications allowed
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent antiarrhythmics or other medications known to prolong QTc
  • No other concurrent anticancer agents or therapies
  • No concurrent grapefruit juice

Exclusion

    Key Trial Info

    Start Date :

    November 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    28 Patients enrolled

    Trial Details

    Trial ID

    NCT01208441

    Start Date

    November 1 2010

    Last Update

    September 30 2013

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    University of Alabama at Birmingham

    Birmingham, Alabama, United States, 35294

    2

    Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, United States, 15213

    3

    University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, United States, 15232