Breast NeoplasmsPhase 2NCT06464913
Randomized Phase II Trial: Chest Wall RT Omission After Prosthetic Reconstruction
A Phase 2 study testing With or without chest wall RT in people with Breast Neoplasms, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this randomized Phase II clinical trial is to test the effects of omitting chest wall radiotherapy (RT) after prosthetic reconstruction in early-stage breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- With or without chest wall RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Sep 2029
- Phase
- Phase 2
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoes prosthetic reconstruction (including cold knife one-step prosthetic reconstruction or two-step expander-prosthetic reconstruction.);
- Histologically confirmed invasive breast cancer patients with stage T1-2N1M0;
- ECOG score of 0-1;
- Indications for neoadjuvant therapy before surgery and adjuvant therapy after surgery.
Who cannot join
- Other metabolically active malignant tumors;
- Severe dysfunction of heart, lung, liver, kidney, or other vital organs;
- Uncontrolled diabetes or other endocrine diseases;
- Known allergy to radiotherapy or chemotherapy drugs;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Ting Zhang, Prof., +8615157125533, zezht@zju.edu.cn
About this study
Official title: A Randomized Phase II Trial on Omission of Chest Wall Radiotherapy After Implant-Based Breast Reconstruction in Early Breast Cancer Patients
The goal of this randomized Phase II clinical trial is to test the effects of omitting chest wall radiotherapy (RT) after prosthetic reconstruction in early-stage breast cancer patients. The main questions it aims to answer are:
- Can omitting chest wall RT after prosthetic reconstruction reduce the failure rate of breast reconstruction without significantly increasing the local recurrence rate?
- Does this approach ensure an improvement in the quality of life for patients without sacrificing therapeutic effectiveness?
Read more
Participants will:
- Be randomly assigned to one of two groups.
- One group will receive standard RT to the chest wall and supraclavicular and infraclavicular lymphatic drainage areas.
- The other group will have chest wall RT omitted and will only receive RT to the supraclavicular and infraclavicular lymphatic drainage areas.
- Participate in follow-up assessments to monitor reconstruction failure rates and local recurrence rates.
If there is a comparison group: Researchers will compare the outcomes of the two groups to evaluate the impact of chest wall RT omission on reconstruction failure and local recurrence risks.
Read the detailed description
Breast reconstruction, as part of the surgical treatment for breast cancer, offers an opportunity for patients who have undergone mastectomy to restore their body image and mental state, while post-mastectomy radiation therapy (PMRT) has advantages in local control and long-term survival of breast cancer. However, the integration of PMRT with reconstruction, especially using implants, raises concerns due to potential complications and the risk of reconstruction failure.
Reconstruction methods include autologous tissue and prosthetic implants, with the latter becoming more popular due to shorter surgery times and faster recovery. The choice between immediate, delayed, and two-stage reconstruction depends on tumor characteristics and patient factors. PMRT indications are based on tumor features and risks. The 2019 ESTRO expert consensus pointed out that the radiotherapy target area after breast prosthetic implantation should include the chest wall and all high-risk lymphatic drainage areas of the axillary region that have not been removed. While PMRT improves outcomes, it increases complications in implant-based reconstructions. Within two years after prosthetic reconstruction surgery, the proportion of patients who have at least one complication after radiotherapy is 39%, while it is 22% for patients who have not received radiotherapy. Early complications include fat or flap necrosis, thrombosis, infection, hematoma, delayed wound healing, and late complications include pain, prosthetic contracture, prosthetic exposure or rupture, and a decline in various indicators of aesthetic results. Patients who ultimately have to remove the implant or convert to autologous tissue reconstruction due to severe complications are defined as reconstruction failure. Among patients who received implant reconstruction and radiotherapy, the proportion of reconstruction failure after two years is the highest (18.7%); in contrast, the failure rate in the non-radiotherapy group or autologous reconstruction group is less than 5%.
Considering the high incidence of complications after prosthetic implantation, the failure rate of breast reconstruction may exceed 20%, while the local recurrence rate after breast reconstruction surgery is around 5%. For early-stage breast cancer patients undergoing cold knife one-step prosthetic reconstruction or two-step expander-prosthetic reconstruction, whether omitting chest wall radiotherapy can reduce the failure of reconstruction without significantly increasing the local recurrence rate, to ensure that improving the quality of life for patients does not sacrifice therapeutic effects. In response to this issue, this project proposes a "randomized Phase II clinical trial of omitting chest wall radiotherapy after prosthetic reconstruction in early-stage breast cancer" prospective study. This study will adopt a randomized controlled method, dividing patients into two groups, one group receiving routine chest wall plus supraclavicular and infraclavicular lymphatic drainage area radiotherapy, and the other group omitting chest wall radiotherapy and only receiving supraclavicular and infraclavicular lymphatic drainage area radiotherapy, aiming to evaluate the impact of omitting chest wall radiotherapy in PMRT after prosthetic reconstruction on the reconstruction failure rate of breast cancer patients, without significantly increasing the risk of local recurrence.
- Conditions
- Breast Neoplasms
- Being tested
- With or without chest wall RT
- Keywords
- Post-mastectomy radiation therapy, Implant-based breast reconstruction, Local recurrence, Reconstruction failure
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With or without chest wall RTRadiation
Supraclavicular and infraclavicular lymphatic drainage area radiotherapy with or without chest wall RT
| Study group | Role | What they receive |
|---|---|---|
| No Chest Wall RT | Experimental | This group will have chest wall RT omitted and will only receive RT to the supraclavicular and infraclavicular lymphatic drainage areas. Receives: Radiation: With or without chest wall RT |
| Traditional RT | Active comparator | This group will receive standard RT to the chest wall and supraclavicular and infraclavicular lymphatic drainage areas. Receives: Radiation: With or without chest wall RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reconstruction failure rate (Capsular Contracture Grade III or higher)
Physicians assess the hardness, shape of the breast, and the presence of any abnormal hard lumps or asymmetry through palpation. According to the Baker classification system, capsular contracture is divided into four grades; Grades I and II typically have no clinical significance, while Grades III and IV require further evaluation and possible treatment.
Breast Ultrasound or Chest CT is used to assess the condition of the implant and surrounding tissues. Particularly, the thickening of the fibrous capsule is considered an objective sign of capsular contracture.
In cases where the results of the ultrasound examination are unclear or a more detailed assessment is needed, MRI may be required to evaluate the implant and surrounding tissues.
Measured: 2 years postoperatively
The 3-year local recurrence rate (LRR)
The 3-year LRR refers to the proportion of patients who experience a cancer recurrence within the breast tissue or chest wall area, or in the regional lymph nodes, within three years following the initial treatment.
To determine the local recurrence rate, medical professionals:
Conduct regular follow-up examinations, including physical assessments and patient-reported symptoms.
Utilize imaging techniques such as mammography, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI) when indicated.
May also consider the use of tumor markers in blood tests to monitor for signs of recurrence.
Measured: 3 years postoperatively
Secondary outcomes (3)
Breast-Q score
The Breast-Q score is a patient-reported outcome measure (PROM) specifically designed to assess the satisfaction and quality of life of patients who have undergone breast surgery.The questionnaire assesses multiple dimensions, including body image, pain, sexual life, and satisfaction, to comprehensively reflect the quality of life and the success of postoperative surgery for patients. Patients self-assess based on the questions in the scale, with each question usually having multiple levels to choose from, and different scores are assigned according to the level selected. The total score is obtained by summing the scores of all questions. The higher the Breast-Q score, the better the patient's quality of life and the greater the satisfaction with the surgery.
Measured: 2 years postoperatively
PROs and QoL score
Satisfaction score (patient-reported outcome) and Quality of Life (QoL) score Measurement Method: A questionnaire is designed based on the assessment dimensions of the patient's physical function, mental health, social function, pain, satisfaction, body image, sexual function, etc., including multiple-choice questions, single-choice questions, scale scoring (such as VAS), open-ended questions, etc.
Measured: 3 years postoperatively
3-year disease free survival rate (DFS)
The 3-year DFS rate refers to a percentage of patients who are disease-free at the three-year mark after their initial treatment. Researcher conduct regular follow-up assessments, including physical examinations and patient-reported outcomes. Utilize imaging studies such as mammograms, CT scans, MRI, or PET scans when appropriate. Monitor for any signs or symptoms that may indicate a recurrence of the disease.
Measured: 3 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Sep 2024
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464913
- Sponsor's protocol ID
- Y2024-0423
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial on Omission of Chest Wall Radiotherapy After Implant-Based Breast Reconstruction in Early Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06464913
- Acronym / sponsor ID
- Y2024-0423
- Conditions
- Breast Neoplasms
- Keywords
- Post-mastectomy radiation therapy, Implant-based breast reconstruction, Local recurrence, Reconstruction failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 18 Jun 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 randomized Phase II clinical trial is to test the effects of omitting chest wall radiotherapy (RT) after prosthetic reconstruction in early-stage breast cancer patients. The main questions it aims to answer are:
- Can omitting chest wall RT after prosthetic reconstruction reduce the failure rate of breast reconstruction without significantly increasing the local recurrence rate?
- Does this approach ensure an improvement in the quality of life for patients without sacrificing therapeutic effectiveness?
Participants will:
- Be randomly assigned to one of two groups.
- One group will receive standard RT to the chest wall and supraclavicular and infraclavicular lymphatic drainage areas.
- The other group will have chest wall RT omitted and will only receive RT to the supraclavicular and infraclavicular lymphatic drainage areas.
- Participate in follow-up assessments to monitor reconstruction failure rates and local recurrence rates.
If there is a comparison group: Researchers will compare the outcomes of the two groups to evaluate the impact of chest wall RT omission on reconstruction failure and local recurrence risks.
Detailed description
Breast reconstruction, as part of the surgical treatment for breast cancer, offers an opportunity for patients who have undergone mastectomy to restore their body image and mental state, while post-mastectomy radiation therapy (PMRT) has advantages in local control and long-term survival of breast cancer. However, the integration of PMRT with reconstruction, especially using implants, raises concerns due to potential complications and the risk of reconstruction failure.
Reconstruction methods include autologous tissue and prosthetic implants, with the latter becoming more popular due to shorter surgery times and faster recovery. The choice between immediate, delayed, and two-stage reconstruction depends on tumor characteristics and patient factors. PMRT indications are based on tumor features and risks. The 2019 ESTRO expert consensus pointed out that the radiotherapy target area after breast prosthetic implantation should include the chest wall and all high-risk lymphatic drainage areas of the axillary region that have not been removed. While PMRT improves outcomes, it increases complications in implant-based reconstructions. Within two years after prosthetic reconstruction surgery, the proportion of patients who have at least one complication after radiotherapy is 39%, while it is 22% for patients who have not received radiotherapy. Early complications include fat or flap necrosis, thrombosis, infection, hematoma, delayed wound healing, and late complications include pain, prosthetic contracture, prosthetic exposure or rupture, and a decline in various indicators of aesthetic results. Patients who ultimately have to remove the implant or convert to autologous tissue reconstruction due to severe complications are defined as reconstruction failure. Among patients who received implant reconstruction and radiotherapy, the proportion of reconstruction failure after two years is the highest (18.7%); in contrast, the failure rate in the non-radiotherapy group or autologous reconstruction group is less than 5%.
Considering the high incidence of complications after prosthetic implantation, the failure rate of breast reconstruction may exceed 20%, while the local recurrence rate after breast reconstruction surgery is around 5%. For early-stage breast cancer patients undergoing cold knife one-step prosthetic reconstruction or two-step expander-prosthetic reconstruction, whether omitting chest wall radiotherapy can reduce the failure of reconstruction without significantly increasing the local recurrence rate, to ensure that improving the quality of life for patients does not sacrifice therapeutic effects. In response to this issue, this project proposes a "randomized Phase II clinical trial of omitting chest wall radiotherapy after prosthetic reconstruction in early-stage breast cancer" prospective study. This study will adopt a randomized controlled method, dividing patients into two groups, one group receiving routine chest wall plus supraclavicular and infraclavicular lymphatic drainage area radiotherapy, and the other group omitting chest wall radiotherapy and only receiving supraclavicular and infraclavicular lymphatic drainage area radiotherapy, aiming to evaluate the impact of omitting chest wall radiotherapy in PMRT after prosthetic reconstruction on the reconstruction failure rate of breast cancer patients, without significantly increasing the risk of local recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Chest Wall RT | Experimental | Radiation: With or without chest wall RTThis group will have chest wall RT omitted and will only receive RT to the supraclavicular and infraclavicular lymphatic drainage areas. |
| Traditional RT | Active comparator | Radiation: With or without chest wall RTThis group will receive standard RT to the chest wall and supraclavicular and infraclavicular lymphatic drainage areas. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoes prosthetic reconstruction (including cold knife one-step prosthetic reconstruction or two-step expander-prosthetic reconstruction.);
- Histologically confirmed invasive breast cancer patients with stage T1-2N1M0;
- ECOG score of 0-1;
- Indications for neoadjuvant therapy before surgery and adjuvant therapy after surgery.
Key exclusion criteria (5 listed)
- Other metabolically active malignant tumors;
- Severe dysfunction of heart, lung, liver, kidney, or other vital organs;
- Uncontrolled diabetes or other endocrine diseases;
- Known allergy to radiotherapy or chemotherapy drugs;
- Pregnant or lactating women.
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 |
|---|---|---|
| With or without chest wall RTSupraclavicular and infraclavicular lymphatic drainage area radiotherapy with or without chest wall RT | Radiation | No Chest Wall RT, Traditional RT |
Primary outcome
Reconstruction failure rate (Capsular Contracture Grade III or higher)
Time frame: 2 years postoperatively
Physicians assess the hardness, shape of the breast, and the presence of any abnormal hard lumps or asymmetry through palpation. According to the Baker classification system, capsular contracture is divided into four grades; Grades I and II typically have no clinical significance, while Grades III and IV require further evaluation and possible treatment. Breast Ultrasound or Chest CT is used to assess the condition of the implant and surrounding tissues. Particularly, the thickening of the fibrous capsule is considered an objective sign of capsular contracture. In cases where the results of the ultrasound examination are unclear or a more detailed assessment is needed, MRI may be required to evaluate the implant and surrounding tissues.
The 3-year local recurrence rate (LRR)
Time frame: 3 years postoperatively
The 3-year LRR refers to the proportion of patients who experience a cancer recurrence within the breast tissue or chest wall area, or in the regional lymph nodes, within three years following the initial treatment. To determine the local recurrence rate, medical professionals: Conduct regular follow-up examinations, including physical assessments and patient-reported symptoms. Utilize imaging techniques such as mammography, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI) when indicated. May also consider the use of tumor markers in blood tests to monitor for signs of recurrence.
3 secondary outcomes
Breast-Q score
Time frame: 2 years postoperatively
PROs and QoL score
Time frame: 3 years postoperatively
3-year disease free survival rate (DFS)
Time frame: 3 years postoperatively
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 15 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing With or without chest wall RT in people with Breast Neoplasms, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 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 15 Oct 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ting Zhang (+86-571-87783521, zezht@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reconstruction failure rate (Capsular Contracture Grade III or higher) (time frame: 2 years postoperatively). The study lists 2 primary outcomes in all. 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 Oct 2024.