Simvastatin Plus Dual Anti-HER2 Therapy for Metastatic Breast Cancer (SIMPHONY)

STATUS

Recruiting
End date

Dec 18, 2030
participants needed

34
sponsor

Baylor Breast Care Center

Send

Updated on 18 April 2022

See if I qualify

platelet count

ejection fraction

measurable disease

breast cancer

endocrine therapy

metastasis

hormone therapy

HER2

adenocarcinoma

Summary

This study recruits patients with metastatic breast cancer who have progressed on their current regimen of dual anti-HER2 therapy. This study evaluates whether or not the addition of simvastatin to the dual anti-HER2 therapy regimen helps make the tumor respond to the anti-HER2 therapy again. All participants will receive simvastatin in combination with their current anti-HER2 therapy regimen.

Description

This study is recruiting participants with metastatic breast cancer that is HER2 positive. "Metastatic" means that cancer has spread to areas of the body outside of the breast. "HER2 positive" means that a cancer cell has too many HER2 receptors on its surface. HER2 receptors act like copy machines, and help tell cancer cells to grow and multiply.

Drugs known as HER2-targeted therapies are often used to treat HER2-positive cancers. HER2-targeted therapies work by blocking the HER2 protein from telling the cell to grow and divide. Once the protein stops working, the cancer cells can no longer make copies of themselves. Once a cancer cell becomes unable to make copies of itself, the tumor will start to shrink. However, some tumors are able to find other ways to make copies of themselves, even when the HER2 protein is blocked. When this happens, the cancer will start to grow again. Researchers believe that adding a drug called simvastatin to an anti-HER2 therapy regimen may cause the cancer to start responding again to your HER2-medications.

Simvastatin is a drug that is approved by the Food and Drug Administration (FDA) to treat high cholesterol. Laboratory research has shown that simvastatin together with dual HER2-targeted therapy slows the growth of breast cancer tumors that had been growing on dual HER2-targeting therapy alone.

Details

Condition	Breast Cancer Stage IV
Treatment	simvastatin 40mg, Simvastatin 80mg
Clinical Study Identifier	NCT03324425
Sponsor	Baylor Breast Care Center
Last Modified on	18 April 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Signed informed consent
	Patients must have histologically confirmed and documented adenocarcinoma of the breast with metastatic disease not amenable to curative therapy
	Cancer must be HER2-positive, according to ASCO-CAP guidelines. Any ER and PR status is allowed
	Participants must have documented disease progression while receiving dual anti-HER2 targeted therapy for metastatic breast cancer, as per investigator assessment. Any combination of biologic therapies is acceptable. Prior chemotherapy is acceptable, but patients must have been off cytotoxic chemotherapy for at least 1 month. Patients with ER-/HER2+ disease have must be failed at least 1 line of chemotherapy in the metastatic setting. Patients with ER+/HER2+ disease who progressed on dual anti-HER2 therapy plus endocrine therapy are eligible. Concomitant endocrine therapy is acceptable and may be continued at the discretion of the treating physician
	Patient must be female and at least 18 years of age
	Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
	Patients must have measurable disease, per RECIST criteria v1.1.21
	Participants must not have undergone major surgery or radiation therapy within 28 days prior to beginning treatment with simvastatin. Any toxicity from prior surgical or radiation treatment must have sufficiently resolved prior to study entry, as determined by the treating physician
	Estimated life expectancy of ≥ 12 weeks
	Ability to swallow oral medications
	Participants must have adequate organ function as defined by
	ANC ≥1.5 x 109/L, platelet count ≥100 x 109/L, haemoglobin ≥ 10 g/dL
	creatinine < 1.5 x UNL (upper normal limit)
	Total bilirubin < 1.5x UNL
	ALT & AST < 2.5xUNL; alkaline phosphatase < 2.5xUNL
	Creatine phosphokinase (CPK) ≤ 2.5 x UNL
	Baseline left ventricular ejection fraction (LVEF) ≥ 50% as determined by either
	echocardiography (ECHO) or multi gated acquisition (MUGA) scan
	Patients with CNS metastatic disease are allowed if the disease is controlled and stable for at least 3 months by CT or MRI
	Negative pregnancy test within 7 days prior to study treatment start, for women of childbearing potential. Women of childbearing potential must agree to use an adequate form of contraception for the duration of their study participation
Exclusion Criteria
	Patients currently treated with a statin or who have been treated with a statin in the past 2 months are ineligible for this study
	Known hypersensitivity to statins
	Prior history of rhabdomyolysis
	Patients who consume more than 3 alcoholic beverages per day
	Lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medications
	Current severe, uncontrolled systemic disease (e.g. pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures)
	Poorly controlled hypertension at the physician's discretion or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA) / stroke within ≤ 6 months prior to the first study treatment, myocardial infarction within ≤ 6 months prior to the first study treatment, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia requiring medication
	Current or past infection with Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV)
	Receipt of IV antibiotics for infection within 7 days of study enrollment
	History of other malignancies within the last 2 years, except for carcinoma in situ of the cervix or basal cell carcinoma
	Participants with bone-only disease are excluded, unless a measureable lesion is present, as defined by RECIST 1.1
	Patients who suffer from a medical or psychiatric condition that, in the opinion of the principal investigator, would impair their ability to participate in the study
	Concurrent interventional studies

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Simvastatin Plus Dual Anti-HER2 Therapy for Metastatic Breast Cancer (SIMPHONY)