A Phase 2 interventional study of Response-adapted preoperative radiotherapy and Guideline-recommended neoadjuvant systemic therapy in Invasive Breast Cancer, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Phase 2, Interventional, and Treatment
RAPID-NeoBC is a prospective, multicentre, response-adapted study with a randomized component for adults with operable, nonmetastatic invasive breast cancer receiving guideline-recommended neoadjuvant systemic therapy. After two treatment cycles, participants with stable disease on blinded central imaging review are randomized 1:1 to continue standard care alone or to receive standard care plus response-adapted preoperative radiotherapy. The primary outcome is centrally reviewed pathological complete response in the breast and sampled regional lymph nodes, defined as ypT0/is ypN0. Participants with complete or partial response continue standard care. Participants with disease progression may enter a nonrandomized radiotherapy rescue pathway if protocol criteria are met. Eligible participants are followed after surgery for recurrence, survival, safety, quality of life, function, and other protocol-defined outcomes.
All participants receive guideline-recommended neoadjuvant systemic therapy selected by the treating physician and multidisciplinary team. The protocol does not assign the systemic regimen. Contrast-enhanced breast magnetic resonance imaging and breast-specific gamma imaging are performed at baseline and after two treatment cycles. Response routing is based on blinded independent central review.
Participants with stable disease are eligible for central 1:1 randomization to standard care alone or standard care plus response-adapted preoperative radiotherapy. Approximately 200 participants will be registered so that 44 participants with stable disease can be randomized (22 per arm; randomization capped at 50). Randomization is stratified by molecular subtype. Central pathologists who assess the primary endpoint are not informed of randomized assignment. Every research radiotherapy plan requires prospective central quality-assurance review and compliance with organ-at-risk constraints.
Participants with complete or partial response continue standard care without research radiotherapy. Participants with disease progression undergo restaging and multidisciplinary review and may enter a nonrandomized rescue pathway in which research radiotherapy is planned unless distant progression, dose constraints, medical risk, or participant preference precludes treatment. After neoadjuvant therapy, eligible participants enter prospective surgical follow-up. Surgery is selected through routine multidisciplinary care and is not assigned by the protocol.
Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 90 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
Participants with complete or partial response after two cycles continue physician-selected standard neoadjuvant systemic therapy without research preoperative radiotherapy.
Other: Guideline-recommended neoadjuvant systemic therapy · Diagnostic Test: Serial contrast-enhanced breast MRI and breast-specific gamma imaging
Participants with stable disease are randomized to continue physician-selected standard neoadjuvant systemic therapy without research preoperative radiotherapy.
Other: Guideline-recommended neoadjuvant systemic therapy · Diagnostic Test: Serial contrast-enhanced breast MRI and breast-specific gamma imaging
Participants with stable disease are randomized to standard neoadjuvant systemic therapy plus centrally reviewed response-adapted preoperative radiotherapy.
Radiation: Response-adapted preoperative radiotherapy · Other: Guideline-recommended neoadjuvant systemic therapy · Diagnostic Test: Serial contrast-enhanced breast MRI and breast-specific gamma imaging
Participants with disease progression after two cycles undergo restaging and multidisciplinary review and may receive research preoperative radiotherapy unless a protocol-defined exemption applies.
Radiation: Response-adapted preoperative radiotherapy · Other: Guideline-recommended neoadjuvant systemic therapy · Diagnostic Test: Serial contrast-enhanced breast MRI and breast-specific gamma imaging
Eligible breast primary tumors smaller than 5 cm receive 24 Gy in 3 fractions when stereotactic constraints are met. Tumors at least 5 cm, or tumors unsuitable for whole-target stereotactic treatment but eligible for spatially fractionated treatment, may receive a peripheral dose of 20 Gy in 5 fractions with intratumoral vertices of 66.7 Gy in 5 fractions. Pathologically confirmed regional nodes are treated according to size, anatomy, dose constraints, and central approval. All plans require prospective central quality-assurance review.
Also known as: neo-RT, SBRT, SFRT, lattice radiotherapy
The treating physician and multidisciplinary team select a curative-intent regimen. The protocol does not assign, provide, or modify systemic therapy. HER2-positive disease includes anti-HER2 therapy, and at least six cycles or the regimen-defined complete course is planned.
Paired examinations are performed at baseline, after cycle 2 and before cycle 3, and before surgery. MRI response is assessed centrally using RECIST 1.1 and directs response-adapted routing after cycle 2.
Pathological Complete Response in the Breast and Regional Lymph Nodes
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.
Time frame: 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.
Residual Cancer Burden
Residual Cancer Burden continuous score and categories RCB-0, RCB-I, RCB-II, and RCB-III based on surgical pathology and central review.
Time frame: At definitive surgery after neoadjuvant therapy.
R0 Resection Rate
Proportion of participants undergoing definitive surgery with microscopically margin-negative resection.
Time frame: At definitive surgery.
Breast-Conserving Surgery Rate
Proportion of participants whose definitive breast procedure is breast-conserving surgery or a protocol-defined breast de-escalation procedure.
Time frame: At definitive surgery.
Axillary Surgery De-escalation Rate
Proportion of participants entering the surgical cohort whose prespecified operative strategy avoids axillary lymph-node dissection and uses protocol-defined regional radiotherapy when indicated.
Time frame: At preoperative strategy confirmation and definitive surgery.
Three-Year Cumulative Incidence of First Locoregional Recurrence
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.
Time frame: 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.
Adverse Events and Serious Adverse Events
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.
Time frame: 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.
Dose-Limiting Toxicity Related to Preoperative Radiotherapy
Preoperative-radiotherapy-related grade 3 or higher nonhematologic toxicity, including protocol-defined skin, pulmonary, cardiac, brachial-plexus, esophageal, surgical-delay, and wound-healing events.
Time frame: From the first preoperative radiotherapy fraction through 90 days after surgery; for participants without definitive surgery, through 6 months after the first fraction.
Late Toxicity
Protocol-recorded pulmonary, cardiac, neurologic, breast-fibrosis, upper-limb, and other late toxicities graded using Common Terminology Criteria for Adverse Events Version 6.0.
Time frame: From 90 days after surgery through 5 years after surgery.
Curative Surgery Conversion in the Progressive-Disease Rescue Cohort
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.
Time frame: Within 6 months after central confirmation of progressive disease.
Event-free Survival
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.
Time frame: 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
Disease-free Survival
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.
Time frame: 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
Overall Survival
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.
Time frame: 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).
Objective Imaging Response on Contrast-Enhanced Breast MRI
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.
Time frame: 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.
Reoperation Rate
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.
Time frame: From definitive surgery through 90 days after surgery.
Change in EORTC QLQ-C30 Global Health Status/Quality of Life Score
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.
Time frame: 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.
Physician-Rated Cosmetic Outcome After Breast-Conserving Surgery（rated by the physician）
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.
Time frame: 12 months after surgery, then yearly through 5 years after surgery.
Participant-Rated Cosmetic Outcome After Breast-Conserving Surgery (rated by the participant)
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.
Time frame: 12 months after surgery, then yearly through 5 years after surgery.
Range of Motion on the Treated Side（goniometer, degrees）
Active shoulder flexion, abduction, and external rotation measured in degrees with a goniometer and compared with baseline.
Time frame: Baseline and 3, 6, and 12 months after surgery, then yearly through 5 years after surgery
Arm and Shoulder Pain on the Treated Side（0-10 NRS）
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).
Time frame: Baseline and 3, 6, and 12 months after surgery, then yearly through 5 years after surgery.
Cumulative Incidence of Arm Lymphedema
Arm lymphedema is defined as an increase of 10% or greater in the inter-arm volume difference relative to baseline, with arm volume calculated from circumferences measured at 4 cm intervals using the truncated-cone formula.
Time frame: From definitive surgery through 5 years after surgery, assessed at 3, 6, and 12 months and yearly thereafter.
Local Objective Response After Preoperative Radiotherapy in the Progressive-Disease Rescue Cohort
Proportion of participants in the progressive-disease rescue cohort who receive preoperative radiotherapy and achieve complete or partial response of irradiated breast and nodal disease on contrast-enhanced MRI according to RECIST 1.1, compared with the post-progression restaging MRI.
Time frame: 4 weeks (plus or minus 1 week) after the last preoperative radiotherapy fraction.
Pathological Complete Response in the Progressive-Disease Rescue Cohort
Proportion of participants in the progressive-disease rescue cohort with ypT0/is ypN0 on blinded central pathology review, reported descriptively with Clopper-Pearson 95% confidence intervals.
Time frame: At definitive surgery, within 6 months after central confirmation of progressive disease.
Proportion of Participants Entering the Prospective Surgical Cohort
Proportion of registered participants, by response pathway after cycle 2, who complete or medically discontinue neoadjuvant therapy, remain on a curative surgical pathway, and enter the prospective surgical follow-up cohort.
Time frame: From study entry through definitive surgery (approximately 6 months).
Association Between Circulating Tumor DNA Detection and Pathological Complete Response
Proportion of participants with detectable plasma circulating tumor DNA, and the association of ctDNA detection with pathological complete response (ypT0/is ypN0), among participants who consent to optional research blood collection.
Time frame: Blood sampled at baseline, after completion of Cycle 2 (each cycle is 21 days), and before definitive surgery; pathological response assessed at definitive surgery, up to approximately 6 months after study entry.
Completion of Planned Neoadjuvant Systemic Therapy
Proportion of participants completing the regimen and number of cycles documented at study entry. Treatment modifications are categorized by toxicity or access versus insufficient efficacy.
Time frame: 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 approximately 6 months after study entry"。
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual participant data will not be shared outside the study team. Data from participants recruited in China are subject to the Regulations on the Management of Human Genetic Resources and the Personal Information Protection Law of the People's Republic of China, and the ethics approval does not cover external transfer of participant-level data. The study protocol and statistical analysis plan will be made available on ClinicalTrials.gov, and aggregate results will be posted and published.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Second Affiliated Hospital, Zhejiang University, School of Medicine