Phase 2 Breast Cancer Trial, Recruiting NCT01530373 Sponsor: University of Arkansas Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT01530373
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Women who have previously been diagnosed with invasive breast cancer or a non-invasive breast condition called DCIS
  • People currently taking hormone-blocking medications called aromatase inhibitors or tamoxifen
  • People who have not been using hormone replacement therapy for at least one month
  • People aged 18 years or older
  • People who report having hot flashes at least 14 times per week
  • People who have been experiencing hot flashes for at least one month
  • People taking certain antidepressants (such as venlafaxine, paroxetine, citalopram, or sertraline) or a nerve pain medication called gabapentin, provided the dose has not changed in the past 4 weeks

Who may not be able to join:

  • People who have used any other hot flash treatment in the past month, including oestrogen, progesterone-type hormones, male hormones, or gabapentin
  • People currently taking medications called clonidine or solifenacin (those who have stopped taking these for at least one month may be considered eligible — confirm with trial site)
  • People with a history of serious kidney problems or moderate to severe liver problems
  • People currently receiving or planning to receive chemotherapy or radiation therapy within the next 3 months
  • People currently taking certain antidepressants known as tricyclics or MAOIs, or medications called barbiturates, or the drugs pimozide
  • People currently taking a range of medications that interact with a specific liver enzyme called CYP3A4 — this includes some epilepsy, antifungal, antibiotic, and herbal medicines such as St. John's Wort, among others (confirm the full list with the trial site)
  • People with poorly controlled narrow-angle glaucoma, difficulty passing urine, or problems with stomach emptying
  • People with low blood pressure or poorly controlled high blood pressure
  • People with serious heart or blood vessel conditions, including a heart attack within the past 3 months, a recent stroke, certain heart rhythm problems, or a history of fainting episodes
  • People with a known allergy or bad reaction to clonidine or solifenacin
  • People who spend more than half of their waking day in bed due to illness or limited function

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Allen C Sherman, PhD, Universitiy of Arkansas for Medical Sciences

Phone: 501-686-8700

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
University of Arkansas
Registry
ClinicalTrials.gov
Start date
1 February 2012
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Efficacy: hot flash composite and frequency scores (daily diary); Safety: number of clinician-rated adverse events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov