IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases

Part of paid clinical trials in Los Angeles, California.

Sponsor
Alice Chung
Study ID
NCT06092892
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Axilla; Breast
  • Axillary Nodal Disease
  • Breast Cancer
  • Female Breast Cancer
  • Mastectomy; Lymphedema
  • Tumor, Breast

Eligibility Criteria

Sex
FEMALE
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Breast Surgery (BCS or mastectomy) with TAD/SNB — PROCEDURE
    Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy
  • Adjuvant Radiation Therapy — RADIATION
    Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy

Study Details

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. Patient, tumor, and treatment data will be documented.

Key Dates

Start date
Apr 7, 2024
Status verified
May 2026
Primary completion
Apr 30, 2031
Completion
Apr 30, 2031

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm

Primary Outcome Measure

Regional recurrence rate [ Time Frame: 5 Years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
[email protected]
310-423-3713
Scott Karlan, MD (SUB_INVESTIGATOR)
Armando Giuliano, MD (SUB_INVESTIGATOR)
Catherine Dang, MD (SUB_INVESTIGATOR)
Farin Amersi, MD (SUB_INVESTIGATOR)
Alice Chung, MD (PRINCIPAL_INVESTIGATOR)
Marissa Boyle, MD (SUB_INVESTIGATOR)
Kjirsten Carlson, MD (SUB_INVESTIGATOR)
Stephen Shiao, MD PhD (SUB_INVESTIGATOR)
Julie Jang, MD (SUB_INVESTIGATOR)
Michele Burnison, MD (SUB_INVESTIGATOR)
Amin Mirhadi, MD (SUB_INVESTIGATOR)
CS Cancer at Huntington Cancer CenterPasadenaCalifornia91105
424-314-0177
Jeannie Shen, MD (SUB_INVESTIGATOR)
Amy Polverini, MD (SUB_INVESTIGATOR)
Alicia Terando, MD (SUB_INVESTIGATOR)
CS Cancer at Valley Oncology Medical GroupTarzanaCalifornia91356
Vanessa Vasco
[email protected]
Lauren DeStefano, MD (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute· Los Angeles, CACS Cancer at Huntington Cancer Center· Pasadena, CACS Cancer at Valley Oncology Medical Group· Tarzana, CA

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