Re-expression of ER in Triple Negative Breast Cancers

• Register: ClinicalTrials.gov
• Last refreshed on: 19 November 2012
• Main ID: NCT01194908
• Date of registration: 01/09/2010
• Primary sponsor: Emory University
• Public title: Re-expression of ER in Triple Negative Breast Cancers
• Scientific title: 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
• Date of first enrolment: July 2010
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01194908
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Ruth O'Regan, MD

• Name: Ruth O'Regan, MD
• Affiliation: Emory University Winship Cancer Institute

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Breast Cancer

Breast Neoplasms

Breast Tumors

Intervention(s)

Drug: Decitabine, LHB589, Tamoxifen

Primary Outcome(s)

To determine the maximum tolerated dose of decitabine and LBH589 given in combination in patients with metastatic or locally advanced metastatic breast cancers [Time Frame: Estrogen receptor status checked 5 days after treatment. Staging is done every 8 weeks.]

Secondary Outcome(s)

To determine the safety of tamoxifen in combination with decitabine and LBH589 [Time Frame: Patients will undergo an evaluation for extent of disease 8 weeks from starting study drugs and every 8 weeks (2 cycles) while on study.]

Secondary ID(s)

WCI1696-09

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eisai Inc.

Novartis