Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

General criteria that apply across multiple groups:

• People with a confirmed invasive breast cancer that has been identified in one area of one breast, with no sign the cancer has spread to distant parts of the body.
• People who are female.
• People who are interested in keeping their breast rather than having it fully removed (breast-conserving surgery).
• People who have had a previous non-breast cancer may still be considered, as long as all treatment for that prior cancer was finished before joining the trial and there is currently no sign of that cancer returning.

Group A1 and A2 — people who may be considered:

• People with a confirmed invasive breast cancer that is no larger than 5 cm, with no more than 4 affected lymph nodes under the arm and no spread to other parts of the body.
• People whose cancer is either HER2-positive (a specific tumour type identified by lab testing) or triple-negative (another tumour type identified by lab testing), and who are receiving standard pre-surgery drug treatment.
• People aged 40 years or older.
• People whose initial lymph node ultrasound did not show more than four suspicious lymph nodes (any suspicious nodes should be sampled and tested).
• People who understand that the breast tumour must measure 2 cm or less on imaging before the study biopsy is done, and that if the biopsy shows remaining cancer, they will be removed from the study.

Group B1 and B2 — people who may be considered:

• People whose cancer is hormone receptor-positive (ER and/or PR positive) and HER2-negative, based on lab testing.
• People with a small, early-stage cancer (clinical stage T1N0M0) that is in one location, is not of the lobular type, and shows no lymphovascular space invasion (no sign of cancer cells in the blood or lymph vessels near the tumour) (confirm with trial site).
• People aged 40 years or older.
• People aged 50 or older with an Oncotype score of 25 or below (Oncotype is a lab test that measures certain features of the tumour).
• People aged 40–49 with an Oncotype score between 0 and 20, and a tumour no larger than 1.5 cm.
• People who agree to take anti-oestrogen (hormone-blocking) medication as part of their treatment.
• People who have not previously had radiation treatment to the breast area that this trial would need to treat.

Group C — people who may be considered:

• People with a confirmed invasive breast cancer that is HER2-positive, no larger than 5 cm, with no lymph node involvement and no distant spread, who are receiving standard pre-surgery drug treatment that includes HER2-directed therapy.
• People with a confirmed invasive breast cancer that is triple-negative, no larger than 2 cm, with no lymph node involvement and no distant spread, who are receiving standard pre-surgery drug treatment.
• People aged 30 or older if the cancer is HER2-positive; people aged 50 or older if the cancer is triple-negative.
• People whose initial lymph node ultrasound showed no suspicious lymph nodes (any suspicious nodes should be sampled and tested).
• People whose surgical specimen (tissue removed during lumpectomy) shows no remaining invasive cancer or pre-invasive cancer (DCIS) on pathology review.
• People whose lymph node tissue shows no remaining cancer or isolated cancer cells on pathology review.
• People whose cancer is in one defined area, or has limited involvement in a small area that can be fully removed in a single surgical specimen.

Group D — people who may be considered (MD Anderson Houston location only):

• People with HER2-positive or triple-negative breast cancer who are suitable for breast-conserving surgery and have received or are planned to receive pre-surgery drug treatment, but who have not enrolled in a treatment arm of the study to skip radiation.
• People in this group may later be considered for moving into Group A or Group C if they meet all the relevant criteria at that later point and wish to consider omitting surgery or radiation.

Who may not be able to join:

• People whose imaging shows a larger or more advanced tumour (stage T3 or T4 in Groups A and C; stage T2, T3, or T4 in Group B).
• People with any clinical or confirmed evidence that the cancer has spread to distant parts of the body.
• People who have previously had invasive breast cancer or a pre-invasive breast condition called ductal carcinoma in situ (DCIS) in the same breast.
• People whose cancer shows signs of having grown by more than 20% or where new lymph node involvement has appeared.
• People who are known to be pregnant.
• People in Groups A or B who are taking part in a pre-surgery drug treatment study that requires surgical removal of breast or lymph node tissue as part of that study.

Important: Always verify eligibility with the trial site directly before applying.