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AzTrials

Breast CancerPhase 2NCT00365599

Phase II Trial of SAHA & Tamoxifen for Patients With Breast Cancer

A Phase 2 study testing suberoylanilide hydroxamic acid (SAHA, Vorinostat) and tamoxifen citrate (Tamoxifen) in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase II trial to explore the efficacy of vorinostat and tamoxifen combined. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
suberoylanilide hydroxamic acid (SAHA, Vorinostat) and tamoxifen citrate (Tamoxifen)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
8 sitesUnited States
Study dates
Feb 2006to Aug 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have cytologically/histologically documented locally advanced or metastatic breast cancer with either:
  • Progression on treatment with any aromatase inhibitor for metastatic disease;
  • Recurrence while on adjuvant aromatase inhibitors or within 12 months of completion;
  • Recurrence after having completed adjuvant tamoxifen for at least 12 months;
  • Patient who are not candidates for or are intolerant of aromatase inhibitor treatment;
  • Patients are allowed (but not required) to have one prior chemotherapy regimen for metastatic disease.
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  • Tumors must express estrogen or progesterone receptor.
  • Patients are eligible regardless of the menopausal status.
  • Age > 18 years old
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Patients must be able to give informed consent and able to follow guidelines given in the study.
  • Patients must have acceptable organ function, as defined by the following laboratory parameters: white blood count (WBC) >3.0 x 10^9/L; absolute neutrophil count (ANC) >1.5 x 10^9/L; hemoglobin (Hgb) >10.0g/dL; platelets (PLT) >100 x 10^9/L, Bilirubin < 2.0 mg/dl, aspartate aminotransferase/alanine aminotransferase (AST/ALT) < 2.5 X upper limit of normal (ULN), Creatinine <1.8 mg/dl (Creatinine clearance >60 ml/min).
  • Women of childbearing age must have a negative pregnancy test. All patients of reproductive potential must use an effective method of contraception during the study and 6 months following termination of treatment. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to female patients who are older than 50 years and have not had a menstrual cycle in more than one year.
  • Patients must have measurable disease by RECIST criteria by staging studies performed within 30 days of enrollment. For patients with bone only disease: For this protocol isolated bone lesions can be classified as target lesions if they are measurable by MRI at screening and must be followed by MRI.
  • Both men and women of all races and ethnic groups are eligible for this trial.

Who cannot join

  • Patients must not have received tamoxifen for metastatic disease.
  • Patients must not have evidence of significant active infection (e.g., pneumonia, cellulitis, wound abscess, etc.) at time of study entry.
  • Patients must be disease-free of prior invasive malignancies for > 5 years with the exception of: curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix.
  • Pregnant and breast-feeding women are excluded from the study because effects on the fetus are unknown and there may be a risk of increased fetal wastage.
  • Patients with uncontrolled central nervous system (CNS) metastasis or a history of seizures are excluded. Patients with stable CNS metastasis (either surgically resected, treated with gamma knife or stable for 3 months following whole brain radiation therapy [WBRT] are eligible). Patients with stable brain metastases will need an MRI within 4 weeks prior to start of therapy.
  • Patients may not be receiving any other investigational agents and must have stopped all other histone deacetylase inhibitors (including Valproic acid) or other hormonal therapies.
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  • Patients must have discontinued their prior therapies for breast cancer and radiation therapy for a minimum of 3 weeks, patient is excluded if radiation therapy was given to a single measurable lesion and the disease is otherwise not measurable.
  • Patients are excluded if they have any known hypersensitivity reaction to tamoxifen.
  • Patient with a history of blood clots are not eligible.
  • Women who have abnormal vaginal bleeding and/or endometrial hyperplasia or cancer are not eligible.
  • Patients with evidence of visceral crisis are not eligible for this study.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Bethesda Memorial Hospital Research Center

    Boynton Beach, Florida, 33435

  • M.D. Anderson of Orlando

    Orlando, Florida, 32806

  • Fawcett Memorial Hospital

    Port Charlotte, Florida, 33949

  • University of California

    San Francisco, California, 94143

  • St. Joseph's/Candler

    Savannah, Georgia, 31405

  • Martin Memorial Cancer Center

    Stuart, Florida, 34994

  • Tallahassee Memorial HealthCare, Inc.

    Tallahassee, Florida, 32308

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Phase II Trial of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) in Combination With Tamoxifen for Patients With Advanced Breast Cancer Who Have Failed Prior Anti-hormonal Therapy.

Phase II trial to explore the efficacy of vorinostat and tamoxifen combined.

Read the detailed description

Phase II trial to explore the efficacy of vorinostat and tamoxifen combined. Tamoxifen will be given once daily, continuously. Vorinostat will be given daily for 3 out of 4 weeks (a cycle). Responses will be assessed (restaged) after 2 cycles and toxicities will be captured continuously. Eligible patients will receive treatment in consecutive 4-week cycles, until progression of disease or unacceptable toxicity. Patients will be followed for evaluation of safety for at least 30 days after the last dose of the study drug.

Tests will be obtained pre-and post vorinostat treatment and correlated with plasma levels of vorinostat at the time of tumor biopsy and vorinostat doses; the tests will consist of:

  • Patient history
  • Physical exam (including height and weight)
  • Toxicity assessment
  • Pharmacokinetic (PK) sample
  • Tumor fine needle aspirate (FNA)
  • Peripheral Blood Mononuclear Cells (PBMC)
  • Standard labs and Chemistry Profile
  • Carcinoembryonic antigen (CEA), cancer antigen (Ca) 15-3, Ca 125 (If clinically indicated)
  • Pregnancy Test
  • Computed tomography (CT) scans, and magnetic resonance imaging (MRI)

Documentation of response and progression will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST).

Conditions
Breast Cancer
Being tested
suberoylanilide hydroxamic acid (SAHA, Vorinostat), tamoxifen citrate (Tamoxifen)
Keywords
Breast cancer, Suberoylanilide hydroxamic acid (SAHA), Vorinostat, Tamoxifen, Anti-hormonal therapy, Estrogen receptor positive, Progesterone receptor positive, Metastatic disease, Aromatase inhibitors (Ais), Histone deacetylase (HDAC) inhibitors, Selective estrogen receptor modulators(SERMS)
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis, Bulbo-Spinal Atrophy, X-Linked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • suberoylanilide hydroxamic acid (SAHA, Vorinostat)Drug

    Also called SAHA, Vorinostat, NSC #701852

    Vorinostat will be used to potentiate the effects of tamoxifen or overcome tamoxifen resistance. All patients will receive vorinostat at 400 mg by mouth (po) daily for 3 out of 4 weeks. Responses will be assessed after 2 cycles (8 weeks + 4 days).

  • tamoxifen citrate (Tamoxifen)Drug

    Also called Nolvadex, Tam, Tamoxifen

    Tamoxifen will be given once daily at 20 mg. Tamoxifen will be given continuously. Responses will be assessed after 2 cycles (8 weeks + 4 days).

Study groups in NCT00365599
Study groupRoleWhat they receive
Vorinostat and TamoxifenExperimentalAs outlined in Intervention descriptions
Receives: Drug: suberoylanilide hydroxamic acid (SAHA, Vorinostat); Drug: tamoxifen citrate (Tamoxifen)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Objective Response (OR)

    The Objective Response Rate. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For the purposes of this study, patients were evaluated for response every 8 weeks. In addition to a baseline scan, confirmatory scans were also obtained ≥ 4 weeks following initial documentation of objective response.

    Measured: 24 weeks

Secondary outcomes (2)

  1. Time to Progression (TTP)

    The median response duration in months. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).

    Measured: Up to 30 months

  2. Number of Participants With Serious Adverse Events (SAEs)

    Safety evaluation according to descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

    Measured: 4 years, 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionApr 2011
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00365599
Sponsor's protocol ID
MCC-14662
Status last verified
Nov 2014
First submitted
15 Aug 2006
Last updated
21 Nov 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing suberoylanilide hydroxamic acid (SAHA, Vorinostat) and tamoxifen citrate (Tamoxifen) in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Objective Response (OR) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00365599.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.

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