Breast Cancer Invasive Clinical Trial
— OPTIMISTOfficial title:
Omission of Breast Surgery for Predicted Pathologic Complete Response Patients With MRI and Vacuum-assisted bIopsy in Breast Cancer After Neoadjuvant Systemic Therapy: a Multicenter, Single-arm, Non-inferiority Trial
NCT number | NCT05505357 |
Other study ID # | KBCSG-24 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 22, 2022 |
Est. completion date | June 2031 |
A prospective, multicenter, single-arm non-inferiority trial to demonstrate that breast cancer patients who are predicted to have a pathologic complete response on MRI and vacuum-assisted biopsy after neoadjuvant systemic therapy, and are omitted breast surgery have a non-inferior 5-year disease-free survival compared to those who had received breast surgery.
Status | Recruiting |
Enrollment | 533 |
Est. completion date | June 2031 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Sex: female - Age: 20 years and older - Patients with no clinical/radiologic distant metastasis - Tumor type: Invasive ductal carcinoma - Tumor subtype: HER2 positive(including luminal B type, triple negative - Extent of disease: initial tumor size = 5cm, cN0-2 - Patients with measurable tumor size - Patients who are expected to achieve pCR after neoadjuvant chemotherapy (MRI size = 1.0 cm AND L-to-B SER = 1.6) - Patients with clip inserted to the primary tumor site before or during neoadjuvant chemotherapy - Patients with informed consent who are competent to make a voluntary decision Exclusion Criteria: - Multifocal lesion (=2) - Extent of residual microcalcification after neoadjuvant chemotherapy > 2cm - Bilateral breast cancer or inflammatory breast cancer - Contraindication to radiotherapy - History of previous contralateral breast cancer - Breast cancer patients with distant metastasis - Allergic history to MRI contrast - Male breast cancer - Patients incapable of giving informed consent owing to poor general conditions - Patients with BRCA mutation - Patients willing to receive breast surgery - Patients with a history of cancer diagnosis within 5 years (However, skin cancer other than melanoma and breast carcinoma in situ other than ductal carcinoma in situ can be registered even if 5 years have not passed since the diagnosis) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Ministry of Health & Welfare, Korea |
Korea, Republic of,
Kim SY, Cho N, Shin SU, Lee HB, Han W, Park IA, Kwon BR, Kim SY, Lee SH, Chang JM, Moon WK. Contrast-enhanced MRI after neoadjuvant chemotherapy of breast cancer: lesion-to-background parenchymal signal enhancement ratio for discriminating pathological complete response from minimal residual tumour. Eur Radiol. 2018 Jul;28(7):2986-2995. doi: 10.1007/s00330-017-5251-8. Epub 2018 Jan 29. — View Citation
Lee HB, Han W, Kim SY, Cho N, Kim KE, Park JH, Ju YW, Lee ES, Lim SJ, Kim JH, Ryu HS, Lee DW, Kim M, Kim TY, Lee KH, Shin SU, Lee SH, Chang JM, Moon HG, Im SA, Moon WK, Park IA, Noh DY. Prediction of pathologic complete response using image-guided biopsy after neoadjuvant chemotherapy in breast cancer patients selected based on MRI findings: a prospective feasibility trial. Breast Cancer Res Treat. 2020 Jul;182(1):97-105. doi: 10.1007/s10549-020-05678-3. Epub 2020 May 16. — View Citation
Tasoulis MK, Lee HB, Yang W, Pope R, Krishnamurthy S, Kim SY, Cho N, Teoh V, Rauch GM, Smith BD, Valero V, Mohammed K, Han W, MacNeill F, Kuerer HM. Accuracy of Post-Neoadjuvant Chemotherapy Image-Guided Breast Biopsy to Predict Residual Cancer. JAMA Surg. 2020 Dec 1;155(12):e204103. doi: 10.1001/jamasurg.2020.4103. Epub 2020 Dec 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-Free Survival | Proportion of patients with no disease recurrence (including loco-regional recurrence, distant metastasis, and contralateral breast cancer) or death. | 5 years after axillary surgery or VAB (in case of axillary surgery omission) | |
Secondary | Ipsilateral Breast Tumor Recurrence-Free Survival Ipsilateral Breast Tumor Recurrence-Free Survival | Proportion of patients with no disease recurrence in the ipsilateral breast or death | 5 years after axillary surgery or VAB (in case of axillary surgery omission) | |
Secondary | Overall Survival | Proportion of patients with no death. | 5 years after axillary surgery or VAB (in case of axillary surgery omission) | |
Secondary | Invasive Disease-Free Survival Invasive Disease-Free Survival | Proportion of patients with no invasive disease recurrence (including loco-regional recurrence, distant metastasis, and contralateral breast cancer) or death. | 5 years after axillary surgery or VAB (in case of axillary surgery omission) | |
Secondary | QoL, symptoms, and medical cost | Analysis of QoL survey (BREAST-Q), procedure-related symptoms, and medical cost | 1 year after axillary surgery or VAB (in case of axillary surgery omission) | |
Secondary | Rate of residual axillary lymph node metastasis on axillary surgery | Proportion of patients with metastatic lymph nodes among those with pCR on VAB | Upon axillary surgery |
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