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 2Interventional Study
Breast CancerAdjuvant TreatmentEarly 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.
Ready to participate?
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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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 standard 5-year treatment are at higher risk of their cancer coming back. The goal of this research is to prevent breast cancer from coming back after surgery by helping women to stay on treatment with aromatase inhibitors. Researchers believe the best path to help women to stay on treatment is to create a better way to manage (control) side effects.
Trial Locations
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Status
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…
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 IHC has not been done)
* Clinical Stage I-III invasive breast cancer or DCIS
* Patients for whom adjuvant treatment with one of the following would be clinically indicated: letrozole, anastrozole, exemestane
* Patients who anticipate continuing with adjuvant endocrine therapy for a minimum of 2 years at the time of registration
* Women over 18 years of age who are post-menopausal, defined as last menstrual period \>2 years prior to registration, or \>1 year prior to registration with FSH and estradiol in post-menopausal range.
* Patients must meet the following clinical laboratory criteria:
* Absolute neutrophil count (ANC) \>1,000/mm3 and platelet count \> 75,000/mm3
* Total bilirubin \<1.5 x the upper limit of the normal range (ULN).
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3 x ULN.
* Ability to give informed consent.
Exclusion Criteria:
* Prior endocrine therapy for any histologically-confirmed cancer or prevention of breast cancer in the last 10 years is not allowed.
* Any other adjuvant therapy for breast cancer. Exception: Bisphosphonate or denosumab treatment for metabolic bone issues are allowed.
* Patients who are prescribed tamoxifen as the first endocrine therapy rather than an aromatase inhibitor.
* Women who are pregnant or lactating.
* Prisoners.
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