Neoadjuvant RadiotherapyNCT06313073
Neoadjuvant Radiotherapy for Breast Cancer
A study testing Neoadjuvant radiotherapy and adjuvant radiotherapy in people with Neoadjuvant Radiotherapy and Breast Cancer, run by Changhai Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the effects of neoadjuvant radiotherapy and adjuvant radiotherapy in patients with breast cancer. The main questions it aims to answer are: The clinical effect of neoadjuvant radiotherapy for breast cancer was determined according to the postoperative specimens. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Neoadjuvant Radiotherapy, Breast Cancer
- What is being tested?
- Neoadjuvant radiotherapy and adjuvant radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female;
- Age range from 18 to 70 years old;
- The pathological diagnosis is invasive cancer, and immunohistochemical examination has been performed to confirm the status of ER, PR, HER2, Ki67, etc;
- Clarify the BRCA gene mutation status;
- Patients who have a baseline stage of T1-3N0-3M0 and meet one of the following conditions and require neoadjuvant therapy: ① mass>5cm; ② Axillary lymph node metastasis; ③ HER-2 positive; ④ Three Yin type; ⑤ Those who have a desire to preserve breast, but have a large ratio of tumor size to breast volume, making it difficult to preserve breast;
- Baseline estimation requires adjuvant radiotherapy, which meets one of the following conditions: ① performing breast conserving surgery; ② T3 or N positive patients after mastectomy and axillary dissection; ③ After mastectomy, sentinel lymph nodes were positive and axillary dissection was not performed;
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- KPS score ≥ 80;
- The tumor must be visible in CT scan;
- Patients must undergo magnetic resonance imaging to help determine the contour of the tumor and exclude other lesions. If other lesions are found, biopsy must be performed on these lesions and the result is negative before continuing treatment;
- No history of serious internal medicine diseases or other serious comorbidities, such as a history of mental illness, allergies, etc;
- Sign an informed consent form.
Who cannot join
- Clinical or pathological stage T4 or M1 breast cancer;
- Received preoperative neoadjuvant therapy;
- Pathological confirmation shows that there is no invasive cancer component in DCIS;
- Double breast cancer or previous contralateral breast cancer;
- Imaging examination suggests suspicious malignant lesions in the ipsilateral or contralateral breast, which have not been pathologically confirmed to be benign;
- KPS score ≤ 70;
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- There is active infection currently;
- Concomitant with severe heart, liver, kidney, hematopoietic and neurological diseases, psychiatric patients, or estimated survival time<6 months;
- History of malignant tumors in other areas, excluding curable non melanoma skin cancer and cervical cancer in situ;
- History of radiation therapy at the site of previous radiation therapy;
- Pregnancy and lactation period;
- Those with poor compliance or life-threatening conditions who cannot complete treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai hospital
Shanghai, Shanghai Municipality, 200433
Huojun Zhang, M.D., +8613311732399, chyyzhj@163.com
Huojun Zhang, M.D.
About this study
Official title: Neoadjuvant Radiotherapy Versus Adjuvant Radiotherapy for Breast Cancer: A Phase II Exploratory Randomized Controlled Clinical Study
The goal of this clinical trial is to compare the effects of neoadjuvant radiotherapy and adjuvant radiotherapy in patients with breast cancer.
The main questions it aims to answer are:
- The clinical effect of neoadjuvant radiotherapy for breast cancer was determined according to the postoperative specimens.
- Evaluate the acute and late toxicity of preoperative radiotherapy Participants will be randomly divided into two groups: the neoadjuvant radiotherapy group and the adjuvant radiotherapy group.
- Conditions
- Neoadjuvant Radiotherapy, Breast Cancer
- Being tested
- Neoadjuvant radiotherapy, adjuvant radiotherapy
- Keywords
- neoadjuvant radiotherapy, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant radiotherapyRadiation
The patient received synchronous radiotherapy and chemotherapy before surgery. CTV : 40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx.CTV : 40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx.
adjuvant radiotherapyRadiation
The patient received radiotherapy after surgery. CTV : 40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx.CTV : 40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant radiotherapy | Experimental | The patient received synchronous radiotherapy and chemotherapy before surgery. CTV : 40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx. Receives: Radiation: Neoadjuvant radiotherapy |
| Adjuvant radiotherapy | Active comparator | The patient underwent postoperative adjuvant radiotherapy. CTV : 40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx. Receives: Radiation: adjuvant radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
pathological complete remission
Measured: up to 3 weeks
Secondary outcomes (1)
RCB
residual cancer burden
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant RadiotherapyStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Huo Jun, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313073
- Sponsor's protocol ID
- CHFL-BC-01
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Radiotherapy Versus Adjuvant Radiotherapy for Breast Cancer: A Phase II Exploratory Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06313073
- Acronym / sponsor ID
- CHFL-BC-01
- Conditions
- Neoadjuvant Radiotherapy, Breast Cancer
- Keywords
- neoadjuvant radiotherapy, breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the effects of neoadjuvant radiotherapy and adjuvant radiotherapy in patients with breast cancer.
The main questions it aims to answer are:
- The clinical effect of neoadjuvant radiotherapy for breast cancer was determined according to the postoperative specimens.
- Evaluate the acute and late toxicity of preoperative radiotherapy Participants will be randomly divided into two groups: the neoadjuvant radiotherapy group and the adjuvant radiotherapy group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant radiotherapy | Experimental | Radiation: Neoadjuvant radiotherapyThe patient received synchronous radiotherapy and chemotherapy before surgery. CTV : 40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx. |
| Adjuvant radiotherapy | Active comparator | Radiation: adjuvant radiotherapyThe patient underwent postoperative adjuvant radiotherapy. CTV : 40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female;
- Age range from 18 to 70 years old;
- The pathological diagnosis is invasive cancer, and immunohistochemical examination has been performed to confirm the status of ER, PR, HER2, Ki67, etc;
- Clarify the BRCA gene mutation status;
- Patients who have a baseline stage of T1-3N0-3M0 and meet one of the following conditions and require neoadjuvant therapy: ① mass>5cm; ② Axillary lymph node metastasis; ③ HER-2 positive; ④ Three Yin type; ⑤ Those who have a desire to preserve breast, but have a large ratio of tumor size to breast volume, making it difficult to preserve breast;
Key exclusion criteria (12 listed)
- Clinical or pathological stage T4 or M1 breast cancer;
- Received preoperative neoadjuvant therapy;
- Pathological confirmation shows that there is no invasive cancer component in DCIS;
- Double breast cancer or previous contralateral breast cancer;
- Imaging examination suggests suspicious malignant lesions in the ipsilateral or contralateral breast, which have not been pathologically confirmed to be benign;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant radiotherapyThe patient received synchronous radiotherapy and chemotherapy before surgery. CTV : 40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx.CTV : 40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx. | Radiation | Neoadjuvant radiotherapy |
| adjuvant radiotherapyThe patient received radiotherapy after surgery. CTV : 40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx.CTV : 40Gy/15fx/3w, sequential GTV： 8.7-10Gy/3-4 Fx. | Radiation | Adjuvant radiotherapy |
Primary outcome
pCR
Time frame: up to 3 weeks
pathological complete remission
1 secondary outcome
RCB
Time frame: up to 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neoadjuvant radiotherapy and adjuvant radiotherapy in people with Neoadjuvant Radiotherapy and Breast Cancer, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024; AzTrials last refreshed its copy on 4 Nov 2026.