Trial · NCT07892508
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathological Complete Response in the Breast and Regional Lymph Nodes | At definitive surgery after completion of planned neoadjuvant therapy; surgery is scheduled 3 to 6 weeks after the final planned systemic-therapy cycle and not earlier than 4 weeks after the last preoperative radiotherapy fraction. | Proportion of randomized participants with no residual invasive cancer in the breast, with ductal carcinoma in situ permitted, and no residual cancer in sampled regional lymph nodes, defined as ypT0/is ypN0 and determined by blinded central pathology review. Participants without evaluable surgery or pathology, or with death, progression preventing surgery, or an efficacy-driven nonprotocol preoperative treatment change, are classified as not achieving pathological complete response under the prespecified analysis rule. |
| Secondary | Residual Cancer Burden | At definitive surgery after neoadjuvant therapy. | Residual Cancer Burden continuous score and categories RCB-0, RCB-I, RCB-II, and RCB-III based on surgical pathology and central review. |
| Secondary | R0 Resection Rate | At definitive surgery. | Proportion of participants undergoing definitive surgery with microscopically margin-negative resection. |
| Secondary | Breast-Conserving Surgery Rate | At definitive surgery. | Proportion of participants whose definitive breast procedure is breast-conserving surgery or a protocol-defined breast de-escalation procedure. |
| Secondary | Axillary Surgery De-escalation Rate | At preoperative strategy confirmation and definitive surgery. | Proportion of participants entering the surgical cohort whose prespecified operative strategy avoids axillary lymph-node dissection and uses protocol-defined regional radiotherapy when indicated. |
| Secondary | Three-Year Cumulative Incidence of First Locoregional Recurrence | From date of first definitive surgery until the date of first documented ipsilateral invasive or in situ breast recurrence, ipsilateral chest-wall recurrence, or regional nodal recurrence, assessed up to 3 years after surgery. | First ipsilateral invasive or in situ breast recurrence, ipsilateral chest-wall recurrence, or regional nodal recurrence after definitive surgery. Death and prior distant recurrence are treated as competing events. |
| Secondary | Adverse Events and Serious Adverse Events | From study entry through 90 days after definitive surgery (up to approximately 9 months after study entry); protocol-defined late effects continue to be collected through 5 years after surgery. | Incidence and maximum severity of adverse events and serious adverse events graded using Common Terminology Criteria for Adverse Events Version 6.0, with relationship to the research intervention recorded. |
| Secondary | Dose-Limiting Toxicity Related to Preoperative Radiotherapy | From the first preoperative radiotherapy fraction through 90 days after surgery; for participants without definitive surgery, through 6 months after the first fraction. | Preoperative-radiotherapy-related grade 3 or higher nonhematologic toxicity, including protocol-defined skin, pulmonary, cardiac, brachial-plexus, esophageal, surgical-delay, and wound-healing events. |
| Secondary | Late Toxicity | From 90 days after surgery through 5 years after surgery. | Protocol-recorded pulmonary, cardiac, neurologic, breast-fibrosis, upper-limb, and other late toxicities graded using Common Terminology Criteria for Adverse Events Version 6.0. |
| Secondary | Curative Surgery Conversion in the Progressive-Disease Rescue Cohort | Within 6 months after central confirmation of progressive disease. | Proportion of participants in the nonrandomized progressive-disease rescue cohort who undergo R0 definitive surgery. The primary descriptive denominator is participants who receive preoperative radiotherapy, with a sensitivity estimate among all participants assigned to the rescue cohort. |
| Secondary | Event-free Survival | From date of randomization (randomized participants) or date of study registration (nonrandomized pathways) until the date of first documented event as defined above or death from any cause, whichever came first, assessed up to 5 years after definitive s | Time from randomization (randomized participants) or from study registration (nonrandomized pathways) to the first of: disease progression precluding definitive surgery; local, regional, or distant recurrence after surgery; contralateral invasive breast cancer; second primary invasive cancer; or death from any cause. Participants without an event are censored at the date of last disease assessment. Results are reported by randomized arm and descriptively for nonrandomized pathways. |
| Secondary | Disease-free Survival | From date of definitive surgery until the date of first documented invasive local, regional, or distant recurrence, contralateral invasive breast cancer, second primary invasive cancer, or death from any cause, whichever came first, assessed up to 5 year | Among participants who undergo definitive surgery, time from surgery to the first of: invasive local, regional, or distant recurrence; contralateral invasive breast cancer; second primary invasive cancer; or death from any cause. Participants without an event are censored at the date of last disease assessment. |
| Secondary | Overall Survival | From date of study registration (all participants) or date of randomization (randomized participants) until date of death from any cause, assessed up to 5 years after definitive surgery (up to approximately 5.5 years after study entry). | Time from study registration (all participants) and from randomization (randomized participants) to death from any cause. Participants alive at last contact are censored at the date last known alive. |
| Secondary | Objective Imaging Response on Contrast-Enhanced Breast MRI | After completion of Cycle 2 and before the start of Cycle 3 (each cycle is 21 days), and before definitive surgery, which is planned approximately 18 to 24 weeks after study entry. | Proportion of participants with complete or partial response of breast and regional nodal disease on contrast-enhanced MRI according to RECIST 1.1, assessed by blinded independent central review. Concurrent breast-specific gamma imaging functional response is reported descriptively. |
| Secondary | Reoperation Rate | From definitive surgery through 90 days after surgery. | Proportion of participants undergoing definitive surgery who require a further breast or axillary operation because of positive margins, wound non-healing, flap necrosis, or other surgical complications. |
| Secondary | Change in EORTC QLQ-C30 Global Health Status/Quality of Life Score | Baseline, after completion of Cycle 2 (each cycle is 21 days), before definitive surgery, and 3, 6, and 12 months after surgery, then yearly through 5 years after surgery. | Health-related quality of life measured with the EORTC QLQ-C30 and the breast cancer module QLQ-BR23, scored according to the EORTC QLQ-C30 Scoring Manual (3rd edition) on 0-100 scales. The key summary measure is the change in QLQ-C30 global health status/quality of life score from baseline to 12 months after surgery; functional and symptom scales are reported descriptively. |
| Other | Physician-Rated Cosmetic Outcome After Breast-Conserving Surgery（rated by the physician） | 12 months after surgery, then yearly through 5 years after surgery. | Proportion of participants with an excellent or good cosmetic outcome on the 4-point Harvard scale (excellent, good, fair, poor), rated separately by a physician, among participants who undergo breast-conserving surgery. |
| Other | Participant-Rated Cosmetic Outcome After Breast-Conserving Surgery (rated by the participant) | 12 months after surgery, then yearly through 5 years after surgery. | Proportion of participants with an excellent or good cosmetic outcome on the 4-point Harvard scale (excellent, good, fair, poor), rated separately by the participant, among participants who undergo breast-conserving surgery. |
| Other | Range of Motion on the Treated Side（goniometer, degrees） | Baseline and 3, 6, and 12 months after surgery, then yearly through 5 years after surgery | Active shoulder flexion, abduction, and external rotation measured in degrees with a goniometer and compared with baseline. |
| Other | Arm and Shoulder Pain on the Treated Side（0-10 NRS） | Baseline and 3, 6, and 12 months after surgery, then yearly through 5 years after surgery. | Active shoulder flexion, abduction, and external rotation measured in degrees with arm and shoulder pain on a 0-10 numeric rating scale (0 = no pain, 10 = worst pain imaginable). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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