Switching Medications for Side Effects in Breast Cancer

Evaluating the Use of a Medication 'Switch' vs Guideline-directed Interventions for Relieving Side Effects of Aromatase Inhibitors Among Breast Cancer Patients

Recruiting Phase 2 Interventional Study
Breast Cancer Adjuvant Treatment Early Stage Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
62 (estimated)
Sponsor
Dartmouth-Hitchcock Medical Center · Other
Who this trial is looking for

This trial is looking for women with early-stage breast cancer who are starting treatment with aromatase inhibitors. Taking part involves managing side effects to help women stay on their treatment for a minimum of two years.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with DCIS or invasive breast cancer.
  • I have estrogen receptor-positive cancer.
  • I have HER2-negative invasive cancer.
  • I have clinical Stage I-III breast cancer or DCIS.
  • I can take letrozole, anastrozole, or exemestane.
  • I plan to continue treatment for at least 2 years.
  • I am post-menopausal and over 18 years old.
  • I meet the lab requirements for blood counts and liver function.

You may not be able to join if

  • I have had prior hormone therapy for any cancer in the last 10 years.
  • I have had any other adjuvant therapy for breast cancer.
  • I am prescribed tamoxifen instead of an aromatase inhibitor.
  • I am pregnant or breastfeeding.
  • I am a prisoner.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
Researchers have learned that about 50% of women do not finish the standard 5-year breast cancer treatment with an aromatase inhibitor. An aromatase inhibitor is hormone therapy that lowers the chance of breast cancer coming back (recurring) after surgery by blocking an enzyme in fat tissue called aromatase; aromatase changes other hormones in the body to estrogen. Women who do not complete the st…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Histologic documentation of DCIS or invasive breast cancer by core needle or incisional biopsy. * The DCIS or invasive cancer must be estrogen receptor alpha (ER)-positive * The invasive cancer must be HER2-negative (IHC 0-1+, or with a FISH ratio of \<1.8 if IHC is 2+ or if I…
Contacts

Kristina M. Willey

603-650-7705

Kristina.M.Willey@hitchcock.org

CONTACT