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New treatment option for Estrogen Receptor Negative
Official title Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy
ClinicalTrials.gov ID: NCT02945579
What this study is testing
- What it's testing
- This clinical trial studies eliminating surgery and/or radiation therapy in treating breast cancer patients. In HER2 positive and triple negative breast cancers, after systemic therapy, when image-guided biopsy shows no residual cancer, patients then receive standard breast radiotherapy with no surgery.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older, women only
You may be able to join if
- 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...
- Pathologically confirmed unicentric invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0 or N1 (≤ 4 abnormal axillary...
- HER2 positive (IHC 3+ and or FISH amplified) or triple receptor negative (TN, ER/PR\< 10% HER2 negative (IHC 1+ or 2+...
- Patient desires breast conserving therapy.
You likely can't join if
- 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...
- Clinical or pathologic evidence for distant metastases.
- Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breast.
- Clinical evidence of progression of disease \>20% in the breast or new evidence of nodal metastases.
- Patient is known to be pregnant.
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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.
- 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...
- Patient desires breast conserving therapy.
- 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].
- Female sex.
- 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...
- 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.
- Patient understands that the breast lesion size on final breast imaging must be less than or equal to 2 cm prior to the biopsy procedure being performed on study and if the biopsy shows residual carcinoma the patient...
- 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...
- ER and/or PR positive, HER2 negative
- Clinical stage T1N0M0, unicentric non-lobular breast cancer, no lymphovascular space invasion,
- At least 40 years of age.
- Oncotype ≤ 25 if age ≥ 50 years
- Oncotype 0-20 and tumor size ≤ 1.5cm if age 40-49 years.
- Patient agrees to take anti-estrogen therapy and is interested in breast conservation
- Female sex.
- 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...
- 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...
- 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...
- 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...
- Patient desires breast conserving therapy.
- Age 30 years or older if HER2 positive. Age 50 or older if HER2 negative (triple negative).
- Female sex.
- 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...
- 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.
- Patient must have no evidence of residual invasive tumor or DCIS on pathologic review of the lumpectomy surgical specimen
- Patient must have no evidence of metastatic disease or isolated tumor cells involving the lymph nodes on pathologic review of the lymph node surgical specimen. If treatment effect in the nodes is noted on the pathology...
- Unifocal disease or limited multifocal disease that can be excised in a single lumpectomy specimen
- Cohort D (MD Anderson Houston patients only)
- Conditions for patient eligibility: Patients on this portion of the study meet all eligibility requirements for cohort C, but have not enrolled onto the study to omit radiation. Patients in Cohort D can be identified at...
What rules you out
- 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.
- Clinical or pathologic evidence for distant metastases.
- Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breast.
- Clinical evidence of progression of disease \>20% in the breast or new evidence of nodal metastases.
- Patient is known to be pregnant.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Jacksonville, Florida, United States
- Honolulu, Hawaii, United States
- Rochester, Minnesota, United States
- Voorhees Township, New Jersey, United States
- Charlotte, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Jacksonville, Florida, United States; Honolulu, Hawaii, United States; Rochester, Minnesota, United States; Voorhees Township, New Jersey, United States; Charlotte, North Carolina, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.