Breast CancerPICBNCT04960839
Prophylactic Irradiation to the Contralateral Breast for BCAs Patients
A study testing Prophylactic contralateral breast irradiation in people with Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 8 sites in 2 countries.
Trial summary
Breast cancer is the most common cancer in women worldwide, with high mortality. About 5% to 10% of breast cancers are hereditary. Most inherited cases of breast cancer are associated with germline mutations in genes, such as BRCA1, BRCA2 and PALB2. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Prophylactic contralateral breast irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Jan 2023to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients, aged 30-70yrs, diagnosed with stage 0-III breast cancer (NCCN-Breast Cancer V2.2019), undergoing the lumpectomy or mastectomy no more than 1 year. ALND or SLNB should be carried out and the lymph node status should be known.
- Patients with a deleterious germline mutation of BRCA 1/2 or PALB2.
- The patients with no contraindictation for irradiation.
- The patients consent for prophylactic irradiation to the contralateral breast.
- The patient may receive any regimen of adjuvant, neoadjuvant chemotherapy, according to the treating physician. The radiation therapy should start at least 2 weeks after the completion of all the chemotherapy cycles.
- The patient may receive endocrine therapy before, during or after study entry.
Show all 9Show fewer
- The patient may receive target therapy (Trastuzumab) before, during or after study entry.
- The patient must be eligible for MRI examination of the contralateral breast.
- The patient refused prophylactic contralateral mastectomy and oophorectomy.
Who cannot join
- Metastatic breast cancer.
- Past history of other cancer besides breast cancer
- Previous irradiation of the breast or chest wall, but not for breast cancer treatment
- Synchronous bilateral breast cancer
- Patients with active connective tissue diseases, pneumonia are excluded due to the potential risk of significant radiotherapeutic toxicity.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
China7 sites, 7 recruiting
- Not yet recruiting
Department of Breast Surgery, Cancer Hospital of University of Chinese Academy of Sciences
Hangzhou, Zhejiang, 310000
Xiaowen Ding, M.D.
- Not yet recruiting
Department of Breast Surgery, the First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Peifen Fu, M.D.
- Recruiting
Department of Breast Surgery, the Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Yiding Chen, M.D.
- Not yet recruiting
Department of Surgical Oncology, Sir Run Run Shaw Hospital, Zhejiang University
Hangzhou, Zhejiang, 310000
Weijun Cjen, M.D.
- Not yet recruiting
Department of Oncology, Zhejiang Hospital
Hangzhou, Zhejiang
Zhibing Wu
- Not yet recruiting
Department of Breast Surgery, Jiangxi Provincial Cancer Hospital
Jiangxi, Jiangxi
Zhengkui Sun, M.D.
- Not yet recruiting
Department of Breast Surgery, Obestrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality
Kejin Wu, M.D.
Singapore1 site, 1 recruiting
- Not yet recruiting
Department of Breast Surgery, Yong Loo Lin School of Medicine, National University of Singapore
Singapore
Mikael Hartman
About this study
Official title: Phase II Multicenter Clinical Trial of Prophylactic Irradiation to the Contralateral Breast for Breast Cancer Patients With BRCA1, BRCA2 and PALB2 Deleterious Mutation
Breast cancer is the most common cancer in women worldwide, with high mortality. About 5% to 10% of breast cancers are hereditary. Most inherited cases of breast cancer are associated with germline mutations in genes, such as BRCA1, BRCA2 and PALB2. The cumulative breast cancer risk for BRCA1, BRCA2 or PALB2 mutation carriers was high.
Besides the increased breast cancer risk for the inherited mutation carriers, the risk of subsequent contralateral breast cancer for the mutation carriers with breast cancer was also significantly increased. Contralateral prophylactic mastectomy was usually recommended to the breast cancer patients with BRCA mutation. However, many breast cancer patients refused the contralateral prophylactic mastectomy, due to the surgical injury, potential surgical complications, deleteriously affected body image and sexuality.
Solid evidence validated that radiotherapy after surgery resulted in a reduced local recurrence for three times lower than surgery alone. It is thought that radiation would eliminate the microscopic tumors which may already exist in the breast. Thus, we proposed that for the breast cancer patients with BRCA1, BRCA2 or PALB2 deleterious germline mutations, prophylactic irradiation to the contralateral breast may reduce the risk of subsequent contralateral breast cancer. And we would like to further compare the effect of prophylactic irradiation to the published data from traditional prophylactic contralateral mastectomy.
Read the detailed description
Breast cancer is the most common cancer in women worldwide, with high mortality. In the US in 2018, the number of estimated new cases of breast cancer accounted for 30% of all the new cancer cases in women, while the estimated deaths of breast cancer accounted for 14% of all new cancer deaths. In Chinese females, the most commonly diagnosed cancer was breast cancer, accounting for 19% of total cases. And breast cancer was the main 5 most common causes of cancer-related deaths in China.
About 5% to 10% of breast cancers are hereditary. Most inherited cases of breast cancer are associated with germline mutations in two genes: BRCA1 (BRCA1 DNA repair associated) and BRCA2 (BRCA2 DNA repair associated). The cumulative breast cancer risk for BRCA1 or BRCA2 mutation carriers at age 70 years reached as high as 50% in US population and 37% in Chinese population. Benefiting from the next generation sequencing technology, more inherited gene mutations were discovered. Among these new discovered susceptibility genes, PALB2 (Partner and localizer of BRCA2) was associated with high increased risks of breast cancer in both Chinese and US population.
Besides the increased breast cancer risk for the inherited mutation carriers, the risk of subsequent contralateral breast cancer for the mutation carriers with breast cancer was also significantly increased. For contralateral breast cancer in BRCA mutation carriers, the cumulative risk for 10 years after breast cancer diagnosis was as high as 25% and for 20 years reached to 40%, as compared 3% and 12% respectively in non-carriers. Contralateral prophylactic mastectomy was usually recommended to the breast cancer patients with BRCA mutation, as it can absolutely reduce the risk of contralateral primary cancer. However, many breast cancer patients refused the contralateral prophylactic mastectomy, due to the surgical injury, potential surgical complications, deleteriously affected body image and sexuality.
Solid evidence validated that radiotherapy after surgery resulted in a reduced local recurrence for three times lower than surgery alone. It is thought that radiation would eliminate the microscopic tumors which may already exist in the breast. Thus, we proposed that for the breast cancer patients with BRCA1, BRCA2 or PALB2 deleterious germline mutations, prophylactic irradiation to the contralateral breast may reduce the risk of subsequent contralateral breast cancer. And we would like to further compare the effect of prophylactic irradiation to the published data from traditional prophylactic contralateral mastectomy.
- Conditions
- Breast Cancer
- Being tested
- Prophylactic contralateral breast irradiation
- Keywords
- BRCA1, BRCA2, PALB2, Deleterious mutation, Prophylactic irradiation, Contralateral breast cancer risk
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic contralateral breast irradiationRadiation
The whole contralateral breast will be irradiated once daily, 5 days a week, for 5-6 weeks, using 1.8-2 Gy/fx to a total dose of 45-50 Gy.
| Study group | Role | What they receive |
|---|---|---|
| Standard group | No intervention | Standard loco-regional treatment without prophylactic contralateral breast irradiation |
| Prophylactic irradiation group | Experimental | Standard loco-regional treatment with prophylactic contralateral breast irradiation Receives: Radiation: Prophylactic contralateral breast irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contralateral breast cancer
The recurrence rate of contralateral breast cancer
Measured: up to 10 years
Secondary outcomes (5)
Overal survival
The length of time from either the date of diagnosis or the start of lumpectomy or mastectomy for primary breast cancer with or without prophylactic irradiation to the contralateral breast
Measured: up to 10 years
Ipsilateral loco-regional recurrence
Reappearance of cancer in the ipsilateral preserved breast, chest wall, axillary or supraclavicular lymph nodes.
Measured: Every 3-6 months. Follow up will be continued until 10 years after lumpectomy or mastectomy for primary breast cancer.
Distant metastasis
Breast cancer that has spread from the original (primary) breast cancer to distant organs or distant lymph nodes.
Measured: up to 10 years
Short time adverse effects
Any short term adverse effects that related to prophylactic irradiation
Measured: 3 months since radiation treatment start
Long time adverse effects
Any long term adverse effects that related to prophylactic irradiation
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Jan 2023 (estimated)
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 323 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peifen Fu, M.D., Principal investigator, Department of Breast Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang UniversityWenjun Chen, M.D., Principal investigator, Department of Surgical Oncology, Sir Run Run Shaw Hospital, Zhejiang UniversityKejin Wu, M.D., Principal investigator, Department of Breast Surgery, Obsterics and Gynecology Hospital of Fudan UniversityXiaowen Ding, M.D., Principal investigator, Department of Breast Surgery, Cancer Hospital of University of Chinese Academy of SciencesZhengkui Sun, Principal investigator, Department of Breast Surgery, Jiangxi Provincial Cancer HospitalMikael Hartman, Principal investigator, Department of Surgery, Yong Loo Lin School of Medicine, National University of SingaporeYiding Chen, Principal investigator, Department of Breast Surgery, The Second Affiliated Hospital, Zhejiang University School of MedicineJiaojiao Zhou, Principal investigator, Departmen of Breast Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960839
- Sponsor's protocol ID
- 2019-228
- Acronym
- PICB
- Status last verified
- Jul 2021
- First submitted
- 12 May 2020
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter Clinical Trial of Prophylactic Irradiation to the Contralateral Breast for Breast Cancer Patients With BRCA1, BRCA2 and PALB2 Deleterious Mutation
- ClinicalTrials.gov ID
- NCT04960839
- Acronym / sponsor ID
- PICB / 2019-228
- Conditions
- Breast Cancer
- Keywords
- BRCA1, BRCA2, PALB2, Deleterious mutation, Prophylactic irradiation, Contralateral breast cancer risk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 14 Jul 2021 (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.
Breast cancer is the most common cancer in women worldwide, with high mortality. About 5% to 10% of breast cancers are hereditary. Most inherited cases of breast cancer are associated with germline mutations in genes, such as BRCA1, BRCA2 and PALB2. The cumulative breast cancer risk for BRCA1, BRCA2 or PALB2 mutation carriers was high.
Besides the increased breast cancer risk for the inherited mutation carriers, the risk of subsequent contralateral breast cancer for the mutation carriers with breast cancer was also significantly increased. Contralateral prophylactic mastectomy was usually recommended to the breast cancer patients with BRCA mutation. However, many breast cancer patients refused the contralateral prophylactic mastectomy, due to the surgical injury, potential surgical complications, deleteriously affected body image and sexuality.
Solid evidence validated that radiotherapy after surgery resulted in a reduced local recurrence for three times lower than surgery alone. It is thought that radiation would eliminate the microscopic tumors which may already exist in the breast. Thus, we proposed that for the breast cancer patients with BRCA1, BRCA2 or PALB2 deleterious germline mutations, prophylactic irradiation to the contralateral breast may reduce the risk of subsequent contralateral breast cancer. And we would like to further compare the effect of prophylactic irradiation to the published data from traditional prophylactic contralateral mastectomy.
Detailed description
Breast cancer is the most common cancer in women worldwide, with high mortality. In the US in 2018, the number of estimated new cases of breast cancer accounted for 30% of all the new cancer cases in women, while the estimated deaths of breast cancer accounted for 14% of all new cancer deaths. In Chinese females, the most commonly diagnosed cancer was breast cancer, accounting for 19% of total cases. And breast cancer was the main 5 most common causes of cancer-related deaths in China.
About 5% to 10% of breast cancers are hereditary. Most inherited cases of breast cancer are associated with germline mutations in two genes: BRCA1 (BRCA1 DNA repair associated) and BRCA2 (BRCA2 DNA repair associated). The cumulative breast cancer risk for BRCA1 or BRCA2 mutation carriers at age 70 years reached as high as 50% in US population and 37% in Chinese population. Benefiting from the next generation sequencing technology, more inherited gene mutations were discovered. Among these new discovered susceptibility genes, PALB2 (Partner and localizer of BRCA2) was associated with high increased risks of breast cancer in both Chinese and US population.
Besides the increased breast cancer risk for the inherited mutation carriers, the risk of subsequent contralateral breast cancer for the mutation carriers with breast cancer was also significantly increased. For contralateral breast cancer in BRCA mutation carriers, the cumulative risk for 10 years after breast cancer diagnosis was as high as 25% and for 20 years reached to 40%, as compared 3% and 12% respectively in non-carriers. Contralateral prophylactic mastectomy was usually recommended to the breast cancer patients with BRCA mutation, as it can absolutely reduce the risk of contralateral primary cancer. However, many breast cancer patients refused the contralateral prophylactic mastectomy, due to the surgical injury, potential surgical complications, deleteriously affected body image and sexuality.
Solid evidence validated that radiotherapy after surgery resulted in a reduced local recurrence for three times lower than surgery alone. It is thought that radiation would eliminate the microscopic tumors which may already exist in the breast. Thus, we proposed that for the breast cancer patients with BRCA1, BRCA2 or PALB2 deleterious germline mutations, prophylactic irradiation to the contralateral breast may reduce the risk of subsequent contralateral breast cancer. And we would like to further compare the effect of prophylactic irradiation to the published data from traditional prophylactic contralateral mastectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | No intervention | –Standard loco-regional treatment without prophylactic contralateral breast irradiation |
| Prophylactic irradiation group | Experimental | Radiation: Prophylactic contralateral breast irradiationStandard loco-regional treatment with prophylactic contralateral breast irradiation |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female patients, aged 30-70yrs, diagnosed with stage 0-III breast cancer (NCCN-Breast Cancer V2.2019), undergoing the lumpectomy or mastectomy no more than 1 year. ALND or SLNB should be carried out and the lymph node status should be known.
- Patients with a deleterious germline mutation of BRCA 1/2 or PALB2.
- The patients with no contraindictation for irradiation.
- The patients consent for prophylactic irradiation to the contralateral breast.
- The patient may receive any regimen of adjuvant, neoadjuvant chemotherapy, according to the treating physician. The radiation therapy should start at least 2 weeks after the completion of all the chemotherapy cycles.
Key exclusion criteria (5 listed)
- Metastatic breast cancer.
- Past history of other cancer besides breast cancer
- Previous irradiation of the breast or chest wall, but not for breast cancer treatment
- Synchronous bilateral breast cancer
- Patients with active connective tissue diseases, pneumonia are excluded due to the potential risk of significant radiotherapeutic toxicity.
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 |
|---|---|---|
| Prophylactic contralateral breast irradiationThe whole contralateral breast will be irradiated once daily, 5 days a week, for 5-6 weeks, using 1.8-2 Gy/fx to a total dose of 45-50 Gy. | Radiation | Prophylactic irradiation group |
Primary outcome
Contralateral breast cancer
Time frame: up to 10 years
The recurrence rate of contralateral breast cancer
5 secondary outcomes
Overal survival
Time frame: up to 10 years
Ipsilateral loco-regional recurrence
Time frame: Every 3-6 months. Follow up will be continued until 10 years after lumpectomy or mastectomy for primary breast cancer.
Distant metastasis
Time frame: up to 10 years
Short time adverse effects
Time frame: 3 months since radiation treatment start
Long time adverse effects
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- 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.
Peifen Fu, M.D. principal investigator
Department of Breast Surgery, The First Affiliated Hospital, College of Medicine, Zhejiang University
Wenjun Chen, M.D. principal investigator
Department of Surgical Oncology, Sir Run Run Shaw Hospital, Zhejiang University
Kejin Wu, M.D. principal investigator
Department of Breast Surgery, Obsterics and Gynecology Hospital of Fudan University
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic contralateral breast irradiation in people with Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 8 sites in 2 countries.
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 9 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China, Singapore. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yiding Chen, M.D. (+86-571-87784527, ydchen@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contralateral breast cancer (time frame: up to 10 years). 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 14 Jul 2021.