IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
Recruiting
Phase 2
Interventional Study
Breast Cancer
Axillary Nodal Disease
Female Breast Cancer
Axilla; Breast
Mastectomy; Lymphedema
Tumor, Breast
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.
At a Glance
- Age
- 45 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 45 (estimated)
- Sponsor
- Alice Chung · Other
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About This Trial
The purpose of the study is to determine the recurrence rates and survival of patients with clinical T1-2N0 ER+/Her2- invasive breast cancer who have biopsy proven image detected nodal disease treated with upfront lumpectomy or mastectomy with TAD followed by adjuvant therapy. This is a prospective, single arm phase II clinical trial. Patients will be screened and enrolled per eligibility criteria…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Women age ≥ 45
* Clinical T1-2N0 ER+ invasive breast cancer
* US detected biopsy proven axillary nodal disease
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
* Palpable nodes on physi…
Contacts