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OncoMatch/Clinical Trials/NCT07071038

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

Is NCT07071038 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Switch for breast cancer.

Phase 2RecruitingDartmouth-Hitchcock Medical CenterNCT07071038Data as of May 2026

Treatment: SwitchResearchers 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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 overexpression (estrogen receptor alpha (ER)-positive)

The DCIS or invasive cancer must be estrogen receptor alpha (ER)-positive

Required: HER2 (ERBB2) negative (IHC 0-1+, or with a FISH ratio of <1.8 if IHC is 2+ or if IHC has not been done) (HER2-negative)

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)

Disease stage

Required: Stage I, II, III, DCIS

Prior therapy

Cannot have received: endocrine therapy

Exception: none in the last 10 years

Prior endocrine therapy for any histologically-confirmed cancer or prevention of breast cancer in the last 10 years is not allowed.

Cannot have received: adjuvant therapy

Exception: Bisphosphonate or denosumab treatment for metabolic bone issues are allowed.

Any other adjuvant therapy for breast cancer. Exception: Bisphosphonate or denosumab treatment for metabolic bone issues are allowed.

Cannot have received: endocrine therapy (tamoxifen)

Patients who are prescribed tamoxifen as the first endocrine therapy rather than an aromatase inhibitor.

Lab requirements

Blood counts

ANC >1,000/mm3 and platelet count > 75,000/mm3

Liver function

Total bilirubin <1.5 x ULN; ALT and AST < 3 x ULN.

Absolute neutrophil count (ANC) >1,000/mm3 and platelet count > 75,000/mm3; Total bilirubin <1.5 x ULN; ALT and AST < 3 x ULN.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Dartmouth Cancer Center · Lebanon, New Hampshire

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