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Phase I/II Trial of Tamoxifen Following Epigenetic Regeneration of Estrogen Receptor Using Decitabine and LBH 589 in Patients With Triple Negative Metastatic Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Breast Tumors, Breast Neoplasms

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Trial Information

Phase I/II Trial of Tamoxifen Following Epigenetic Regeneration of Estrogen Receptor Using Decitabine and LBH 589 in Patients With Triple Negative Metastatic Breast Cancer


Inclusion Criteria:



- Histologically or cytologically confirmed triple negative (ER-, PR-, HER2-)
metastatic or locally advanced breast cancer

- Measurable disease according to the RECIST criteria.

- Disease that is assessable to biopsy for hormone receptor measurement

- At least one line of therapy prior to study entry (acceptable therapies include
chemotherapy ± anti-angiogenic therapy). Other investigational therapies except DNMT
and HDAC inhibitors are allowed.

- Age > 18 years

- ECOG Performance Score of 0 or 1 (Appendix A)

- Adequate bone marrow as evidenced by:

- Absolute neutrophil count > 1,500/uL

- Platelet count > 100,000/uL

- Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL

- Adequate hepatic function as evidenced by:

- Serum total bilirubin < 1.5 mg/dL

- Alkaline phosphatase < 3X the ULN for the reference lab (< 5X the ULN for
patients with known hepatic metastases

- SGOT/SGPT < 3X the ULN for the reference lab (< 5X the ULN for patients with
known hepatic metastases

- Patients must be recovered from both the acute and late effects of any prior surgery,
radiotherapy or other antineoplastic therapy

- Patients or their legal representatives must be able to read, understand and provide
informed consent to participate in the trial.

- Consent to biopsy before and after therapy with decitabine and LBH589.

- Patients of childbearing potential and their partners must agree to use an effective
form of contraception during the study and for 90 days following the last dose of
study medication (an effective form of contraception is an oral contraceptive or a
double barrier method)

Exclusion Criteria:

- Patients with an active infection or with a fever > 101.30 F within 3 days of the
first scheduled day of protocol treatment

- Patients with active CNS metastases. Patients with stable CNS disease, who have
undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment
and who have been on a stable dose of corticosteroids for >3 weeks are eligible for
the trial

- History of prior malignancy within the past 5 years except for curatively treated
basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized
prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at
least 3 months apart, with the most recent evaluation no more than 4 weeks prior to
entry

- Patients with known hypersensitivity to any of the components of decitabine or LBH589

- Patients who received radiotherapy to more than 25% of their bone marrow; or patients
who received any radiotherapy within 4 weeks of entry

- Patients who are receiving concurrent investigational therapy or who have received
investigational therapy within 28 days of the first scheduled day of protocol
treatment (investigational therapy is defined as treatment for which there is
currently no regulatory authority approved indication)

- Peripheral neuropathy >= Grade 2

- Patients who are pregnant or lactating

- Any other medical condition, including mental illness or substance abuse, deemed by
the Investigator to be likely to interfere with a patient's ability to sign informed
consent, cooperate and participate in the study, or interfere with the interpretation
of the results.

- History of allogeneic transplant

- Known HIV or Hepatitis B or C (active, previously treated or both)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose of decitabine and LBH589 given in combination in patients with metastatic or locally advanced metastatic breast cancers

Outcome Time Frame:

Estrogen receptor status checked 5 days after treatment. Staging is done every 8 weeks.

Safety Issue:

Yes

Principal Investigator

Ruth O'Regan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

WCI1696-09

NCT ID:

NCT01194908

Start Date:

July 2010

Completion Date:

July 2016

Related Keywords:

  • Breast Cancer
  • Breast Tumors
  • Breast Neoplasms
  • Breast Cancer
  • Breast Tumors
  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

Name

Location

Emory University Winship Cancer InstituteAtlanta, Georgia  30322