Trial · NCT07892508
Adding Preoperative Radiotherapy Based on Early Treatment Response in Breast Cancer
NCT07892508, Phase 2, Not yet recruiting, Second Affiliated Hospital, Zhejiang University, School of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adding Preoperative Radiotherapy Based on Early Treatment Response in Breast Cancer. Trials, record NCT07892508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07892508
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adding Preoperative Radiotherapy Based on Early Treatment Response in Breast Cancer
- NCT number
- NCT07892508
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 200 participants, estimated
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Conditions
- Invasive Breast Cancer
- Interventions
- Response-adapted preoperative radiotherapy, Guideline-recommended neoadjuvant systemic therapy, Serial contrast-enhanced breast MRI and breast-specific gamma imaging
- First posted
- 2026-10-23
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07892508
GET https://conductscience.org/api/trials/v1/NCT07892508/registered?page=2