Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Cohort A1 and A2
? Conditions for patient eligibility: Patients on this portion of the study can
receive radiation treatment at any MD Anderson Cancer Center or any outside hospital
and may be enrolled prior to, during, or following neoadjuvant systemic therapy
provided they meet the following eligibility and ineligibility requirements noted
below:
1. Pathologically confirmed unicentric invasive breast cancer defined as radiologic
clinical stage T1 or T2 (≤ 5 cm), N0 or N1 (≤ 4 abnormal axillary nodes on
initial ultrasound), clinical stage M0.
2. HER2 positive (IHC 3+ and or FISH amplified) or triple receptor negative (TN,
ER/PR< 10% HER2 negative (IHC 1+ or 2+ FISH non-amplified) receiving any standard
routine clinical NST regimen.
3. Patient desires breast conserving therapy.
4. Age 40 years or older. This age cutoff is justified because breast cancers in
women under the age of 40 are known to have a significantly higher risk of IBTR
presumably due to underlying biologic differences [124, 125].
5. Female sex.
6. If the patient has a history of a prior non-breast cancer, all treatment for this
cancer must have been completed prior to study registration and the patient must
have no evidence of disease for this prior non-breast cancer.
7. Patient must have an initial nodal ultrasound that does not demonstrate more than
four suspicious lymph nodes, any suspicious lymph nodes should be biopsied to
determine if nodal metastatic disease present.
- Cohort B1 and B2
? Conditions for patient eligibility: Patients on this portion of the study will be
limited to receive radiation treatment at MD Anderson Cancer Center or other approved
locations and must be enrolled prior to any neoadjuvant systemic therapy provided they
meet the following eligibility and ineligibility requirements noted below:
1. ER and/or PR positive, HER2 negative
2. Clinical stage T1N0M0, unicentric non-lobular breast cancer, no lymphovascular
space invasion,
3. At least 40 years of age.
4. Oncotype ≤ 25 if age ≥ 50 years
5. Oncotype 0-20 and tumor size ≤ 1.5cm if age 40-49 years.
6. Patient agrees to take anti-estrogen therapy and is interested in breast
conservation
7. Female sex.
8. If the patient has a history of a prior non-breast cancer, all treatment for this
cancer must have been completed prior to study registration and the patient must
have no evidence of disease for this prior non-breast cancer.
9. No history of prior radiation to the area of the breast that would require
protocol-mandated treatment
- Cohort C
- Conditions for patient eligibility: Patients on this portion of the study can
receive surgical treatment at any MD Anderson Cancer Center or any outside
hospital and may be enrolled prior to or following neoadjuvant systemic therapy
provided they meet the following eligibility and ineligibility requirements noted
below:
1. Pathologically confirmed invasive breast cancer defined as radiologic
clinical stage T1 or T2 (≤ 5 cm), N0, clinical stage M0 and HER2 positive
(IHC 3+ and or FISH amplified) receiving any standard routine clinical NST
regimen containing her-2 directed therapy OR Pathologically confirmed
invasive breast cancer defined as radiologic clinical stage T1 (≤ 2 cm), N0,
clinical stage M0 and triple negative, receiving any standard routine
clinical NST regimen.
2. For cohort C patients participating in the optional pretreatment biopsy, the
patient should be able undergo biopsy or surgery of the primary tumor site
of suspected or proven invasive breast cancer and should be planned to
receive neoadjuvant systemic therapy.
3. Patient desires breast conserving therapy.
4. Age 30 years or older if HER2 positive. Age 50 or older if HER2 negative
(triple negative).
5. Female sex.
6. If the patient has a history of a prior non-breast cancer, all treatment for
this cancer must have been completed prior to study registration and the
patient must have no evidence of disease for this prior non-breast cancer.
7. Patient must have an initial nodal ultrasound that does not demonstrate
suspicious lymph nodes; any suspicious lymph nodes should be biopsied to
determine if nodal metastatic disease present.
8. Patient must have no evidence of residual invasive tumor or DCIS on
pathologic review of the lumpectomy surgical specimen
9. Patient must have no evidence of metastatic disease involving the lymph
nodes on pathologic review of the lymph node surgical specimen.
10. Unifocal disease or limited multifocal disease that can be excised in a
single lumpectomy specimen
Exclusion Criteria:
1. Radiologic evidence for a stage T3 or clinical stage T4 breast cancer in Cohort
A1/A2/C; radiologic evidence for a stage T2-T3 or clinical stage T4 breast cancer in
Cohort B1/B2.
2. Clinical or pathologic evidence for distant metastases.
3. Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the
ipsilateral breast.
4. Clinical evidence of progression of disease >20% in the breast or new evidence of
nodal metastases.
5. Patient is known to be pregnant.
6. Patient is participating in a NST protocol in which surgical excision of the breast
and or lymph nodes are required in Cohort A1/A2/B1/B2.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 2/14/2024. Questions regarding updates should be directed to the study team contact.