Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT02510456
Eligibility Criteria:
Inclusion Criteria for Neoadjuvant Chemo (NAC) Cohort:
1. Female;
2. Diagnosis of invasive breast cancer by clinical breast examination, by standard of care diagnostic imaging, or by initial tissue biopsy;
3. Planned for primary systemic (neoadjuvant) chemotherapy and surgical resection of residual primary tumor following completion of neoadjuvant chemotherapy;
4. Tumor size ≥ 2cm, measured on imaging or estimated by physical exam;
5. Planned definitive breast surgery (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant therapy;
6. Age 18 years or older;
7. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 (Karnofsky performance status ≥ 60%;
8. Adequate organ and marrow function, as defined at Boston Medical Center (BMC);
9. Postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by a pregnancy test as per institutional standard of care, and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation;
10. Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.
Inclusion Criteria for Non-NAC Cohort:
1. Female;
2. Diagnosis of invasive breast cancer by clinical breast examination, by standard of care diagnostic imaging, or by initial tissue biopsy;
3. Tumor size ≥2cm, measured on imaging or estimated by physical exam;
4. Planned definitive breast surgery (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant therapy;
5. Age 18 years or older;
6. ECOG Performance Status ≤ 2 (Karnofsky performance status ≥ 60%; see Appendix II);
7. Adequate organ and marrow function, as defined at BMC;
8. Postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by a pregnancy test as per institutional standard of care, and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation;
9. Able to understand and willing to sign a written informed consent document and a HIPAA authorization in accordance with institutional guidelines.
Exclusion Criteria for All Cohorts:
1. Previous treatment (chemotherapy, radiation, or surgery) to involved breast;
2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
3. Medically unstable;
4. Under age 18;
5. Pregnant or nursing;
6. Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years;
7. No contraindications for primary chemotherapy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02510456
Study Brief:
Protocol Section:
NCT02510456