A Study of Changes in Ki67 Expression in People With Breast Cancer Receiving Endocrine Therapy Before Surgery

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

The researchers are doing this study to look at changes in Ki67 expression after at least 2 weeks of endocrine therapy in people with ER+/HER2- breast cancer undergoing cancer removal surgery. Participants will receive the endocrine therapy before their surgery. The researchers will look at how changes in Ki67 expression compare between participants who are carriers of the BRCA2 mutation and participants who are noncarriers of the BRCA2 mutation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Postmenopausal women aged ≥18 years with biopsy-proven stage I-III invasive breast cancer that is ER+/HER2-

Scheduled to undergo upfront surgery

Eligible for genetic testing in accordance with National Comprehensive Cancer Network guidelines(BRCA2 arm only)

Disqualifiers

History of breast cancer

Receipt of ET for risk reduction in the previous 3 months

Stage IV disease at presentation

Scheduled to undergo neoadjuvant systemic chemotherapy

Trial design

Design model

Single group

Treatments tested in this trial

  • blood draw

    Other intervention

    blood draw

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Breast CancerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

assess the change in Ki67

The change in Ki67 expression on immunohistochemical staining from baseline to at least 2 weeks of ET will be assessed.

Time frame
baseline to at least 2 weeks of endocrine therapy

Secondary outcomes

Other outcomes

Sponsors and contacts

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