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Clinical Trial NCT07113613 for Breast Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Prospective Study on Exemption of Tumor Bed Boost Radiotherapy for pCR Patients After Breast Conserving Surgery With Neoadjuvant Therapy Phase 2 150 Dose Escalation
Clinical Trial NCT07113613 is designed to study Treatment for Breast Cancer. It is a Phase 2 interventional study that is recruiting, having started on January 1, 2025, with plans to enroll 150 participants. Led by The First Affiliated Hospital with Nanjing Medical University, it is expected to complete by December 31, 2031. The latest data from ClinicalTrials.gov was last updated on August 11, 2025.
Brief Summary
This study is a multicenter, single-arm, phase II clinical trial, aiming to evaluate the safety and efficacy of tumor bed dose escalation radiotherapy for patients with primary breast lesions achieving pCR (ypT0) after neoadjuvant chemotherapy and breast-conserving surgery.
Detailed Description
New neoadjuvant chemotherapy (NAC) is mainly used for patients with locally advanced or those who wish to preserve their breast. It not only helps to downstage the tumor but also increases the success rate and possibility of breast-conserving treatment for patients. Moreover, NAC provides doctors with the opportunity to assess the chemotherapy response, which can be used to predict the survival of patients. Studies h...Show More
Official Title
A Multicenter, Single-arm Phase II Clinical Study on Exempting Tumor Bed Boost Radiotherapy for Patients Achieving pCR After Breast Conserving Surgery With Neoadjuvant Therapy
Conditions
Breast CancerOther Study IDs
- 2024-SR-983
NCT ID Number
Start Date (Actual)
2025-01-01
Last Update Posted
2025-08-11
Completion Date (Estimated)
2031-12-31
Enrollment (Estimated)
150
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Radiotherapy
Exemption of tumor bed dosage increase
Breast-conserving treatment
Neoadjuvant chemotherapy
Exemption of tumor bed dosage increase
Breast-conserving treatment
Neoadjuvant chemotherapy
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalExempted tumor bed radiotherapy group The total breast irradiation dose was 43.5 Gy/15 fractions, with each fraction being 2.9 Gy, administered once a day, 5 times a week; the dose for the regional lymph nodes was also 43.5 Gy/15 fractions, with each fraction being 2.9 Gy, administered once a day, 5 times a week. | Exemption from additional radiotherapy on the tumor bed after surgery For patients who met the inclusion criteria and were enrolled, postoperative tumor bed boost radiotherapy was waived, and only whole breast and/or regional lymph node irradiation was administered. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
5-year ipsilateral breast recurrence rate (IBTR) | The recurrence of the same-sided breast occurred for the first time within 5 years. | 5 years |
5-year local-regional recurrence (LRR) | Recurrence of the same-side breast, the same-side axillary fossa, the same-side supraclavicular lymph nodes, or the same-side internal mammary lymph nodes for the first time within 5 years. | 5 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Local regional control rate (LRC) | The time from NAC to the occurrence of the first LRR | 5 years |
Disease-free survival time (DFS) | The time from NAC to recurrence or death | 5 years |
Overall survival time (OS) | The time from chemotherapy to death due to any cause | 5 years |
Safety-related study endpoints | acute or chronic radiotherapy-related adverse reactions: including skin damage, breast pain, lung damage, heart damage, upper limb edema, upper limb functional impairment, brachial plexus injury, etc. | 5 years |
cosmetic effect | evaluation of cosmetic effect after breast-conserving surgery using the Harvard standard. | 5 years |
quality of life evaluation | quality of life evaluation using the Chinese version of the QLQ-BR23 scale. | 5 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
30 Years
Eligible Sexes
Female
(1) Voluntary participation, good compliance, able to cooperate with the trial observation, and having signed a written informed consent form; (2) Confirmed as invasive cancer through pathological tissue examination, and received baseline breast MR or PET/MR examination before neoadjuvant therapy; (3) Received the standard neoadjuvant treatment plan recommended by the guidelines based on molecular typing; (4) Single lesion, initially diagnosed as cT1-3N0-3a; (5) Underwent breast-conserving surgery, with negative surgical margins and a margin distance of ≥1mm, and achieved pCR of the primary breast lesion after NAC (ypT0); (6) Age 30-75 years, ECOG score 0-1; (7) Met the basic requirements for adjuvant radiotherapy, including basically normal peripheral blood count, no significant abnormalities in heart, liver, and kidney functions, and basically normal electrocardiogram; (8) Had no previous chest radiotherapy.
(1) Pregnant women, lactating women, or women with reproductive capacity but without contraceptive measures in place; (2) Known to carry mutated susceptibility genes for breast cancer (including BRCA-1 and BRCA-2); (3) Diagnosed with cT4, N3b-c, bilateral breast cancer, with multiple primary lesions, multicentricity or non-bulky enhancement at the primary site; (4) Not receiving the standard neoadjuvant treatment regimen recommended by guidelines, or the primary breast lesion did not achieve pCR (including ypTis) after NAC; (5) Suffering from other malignant tumors or participating in other clinical trials simultaneously; (6) Unable to start radiotherapy within 8 weeks after breast cancer surgery; (7) Diagnosed with distant metastasis through initial imaging or pathology; (8) Previous history of breast cancer, history of radiotherapy in the neck, chest or ipsilateral axilla; (9) Severe non-tumor-related medical comorbidities affecting the implementation of radiotherapy; (10) Suffering from uncontrollable neurological, mental disorders or mental impairments, with poor compliance and inability to cooperate and describe treatment responses.
The First Affiliated Hospital with Nanjing Medical UniversityStudy Responsible Party
Sun Xinchen, Principal Investigator, Director of the Radiotherapy Center, The First Affiliated Hospital with Nanjing Medical University
Study Central Contact
Contact: Xinchen Sun, Doctor, 13770662828, [email protected]
1 Study Locations in 1 Countries
Jiangsu
The First Affiliated with Nanjing Medical University (Jiangsu Province People's Hospital), Nanjing, Jiangsu, 210029, China
Xinchen Sun, Doctor, Contact, 86-13770662828, [email protected]
Recruiting