Local Recurrence of Malignant Tumor of BreastNCT02376413
Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients
An observational study of Local Recurrence of Malignant Tumor of Breast, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast cancer patients. There are evidences indicating that oncoplastic-BCS (displacement technique) could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as traditional BCS does. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Local Recurrence of Malignant Tumor of Breast
- What is being tested?
- Breast surgery, Chemotherapy or endocrine therapy or Trastuzumab therapy and Radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2022
- Phase
- Observational
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Non-metastatic breast cancer patients received surgical treatment in Sun Yat-sen Memorial Hospital, Sun Yat-sen University. Informed consent must be obtained for all of the included patients.
Who may be able to join
- Informed consent signed
- ECOG<=2
- Non-metastatic breast cancer patients with unilateral breast cancer confirmed by pathology.
- Operable or operable after neoadjuvant chemotherapy.
- Extensive, diffuse micro-calcifications on mammography before surgery
- No history of breast surgery or breast radiation therapy before.
- Able to follow the standard of care in adjuvant chemotherapy, radiation therapy, endocrine therapy and targeted therapy after surgery.
Who cannot join
- Multifocal/multicentric diseases noticed before surgery.
- Inflammatory breast cancer or invasive micro-papillary carcinoma of the breast confirmed by pathology before surgery.
- Tumor size > 5 cm revealed by physical examination, Ultrasound or mammography before surgery.
- Tumor size/breast size ratio >0.5 revealed by by physical examination, Ultrasound or mammography before surgery.
- Have other malignant tumors.
- Have severe co-morbidities that compromise the patients' compliance to our protocol, or endanger the patients.
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- Participated in other clinical trials.
- Pathologically confirmed metastatic breast cancer, bilateral breast cancer or DCIS patients.
- Patients with any organ failure.
- Pregnancy women
- Patients who desire to have mastectomy before surgery.
About this study
Official title: Prospective Non-randomized Evaluation of Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients
Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast cancer patients. There are evidences indicating that oncoplastic-BCS (displacement technique) could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as traditional BCS does. However, there are no prospective trial comparing oncoplastic-BCS vs. traditional BCS in terms of cosmetic outcomes and oncological safety. In this study, the investigators are going to address this issue by assigning patients into traditional and oncoplastic-BCS group, based on their preference.
- Being tested
- Breast surgery, Chemotherapy or endocrine therapy or Trastuzumab therapy, Radiation therapy
- Keywords
- Morbidity, The Breast Cancer Treatment Outcome Scale, Disease free survival, Positivity cavity margin rate, Harvard/NSABP/RTOG breast cosmesis grading scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast surgeryProcedure or surgery
Traditional breast-conserving surgery, oncoplastic breast-conserving surgery or modified radical mastectomy
Chemotherapy or endocrine therapy or Trastuzumab therapyDrug
Radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Traditional BCS | Breast-conserving surgery. Modified radical mastectomy. Receives: Procedure: Breast surgery; Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy; Radiation: Radiation therapy | |
| Oncoplastic-BCS | Breast-conserving surgery. Modified radical mastectomy. Oncoplastic-BCS based on surgeon preference and/or tumor location.
* Superior pedicle mammoplasty / inverted T
* Superior pedicle mammoplasty / V scar
* Batwing
* Inferior pedicle mammoplasty
* Racquet mammoplasty/radial scar
* vertical-scar mammoplasty Receives: Procedure: Breast surgery; Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harvard/NSABP/RTOG breast cosmesis grading scale
Measured: 5 years
Secondary outcomes (5)
Positivity rate of cavity margin
Measured: Intraoperatively.
Local-recurrence free survival
Measured: 5 years
Disease free survival
Measured: 5 years
Breast Cancer Treatment Outcome Scale (BCTOS)
Measured: 5 years
Morbidity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Unavailable to recruit patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Recurrence of Malignant Tumor of BreastStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erwei Song, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Erwei Song, M.D. Ph.D., Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityFengxi Su, M.D., Study director, Yat-sen Memorial Hospital, Sun Yat-sen University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376413
- Sponsor's protocol ID
- sysubcr001
- Status last verified
- Dec 2015
- First submitted
- 17 Feb 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-randomized Evaluation of Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02376413
- Acronym / sponsor ID
- sysubcr001
- Keywords
- Morbidity, The Breast Cancer Treatment Outcome Scale, Disease free survival, Positivity cavity margin rate, Harvard/NSABP/RTOG breast cosmesis grading scale
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unavailable to recruit patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 3 Mar 2015 (estimated)
- 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-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast cancer patients. There are evidences indicating that oncoplastic-BCS (displacement technique) could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as traditional BCS does. However, there are no prospective trial comparing oncoplastic-BCS vs. traditional BCS in terms of cosmetic outcomes and oncological safety. In this study, the investigators are going to address this issue by assigning patients into traditional and oncoplastic-BCS group, based on their preference.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional BCS | – | Procedure: Breast surgery, Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy, Radiation: Radiation therapyBreast-conserving surgery. Modified radical mastectomy. |
| Oncoplastic-BCS | – | Procedure: Breast surgery, Drug: Chemotherapy or endocrine therapy or Trastuzumab therapy, Radiation: Radiation therapyBreast-conserving surgery. Modified radical mastectomy. Oncoplastic-BCS based on surgeon preference and/or tumor location. * Superior pedicle mammoplasty / inverted T * Superior pedicle mammoplasty / V scar * Batwing * Inferior pedicle mammoplasty * Racquet mammoplasty/radial scar * vertical-scar mammoplasty |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-metastatic breast cancer patients received surgical treatment in Sun Yat-sen Memorial Hospital, Sun Yat-sen University. Informed consent must be obtained for all of the included patients.
Key inclusion criteria (7 listed)
- Informed consent signed
- ECOG<=2
- Non-metastatic breast cancer patients with unilateral breast cancer confirmed by pathology.
- Operable or operable after neoadjuvant chemotherapy.
- Extensive, diffuse micro-calcifications on mammography before surgery
Key exclusion criteria (11 listed)
- Multifocal/multicentric diseases noticed before surgery.
- Inflammatory breast cancer or invasive micro-papillary carcinoma of the breast confirmed by pathology before surgery.
- Tumor size > 5 cm revealed by physical examination, Ultrasound or mammography before surgery.
- Tumor size/breast size ratio >0.5 revealed by by physical examination, Ultrasound or mammography before surgery.
- Have other malignant tumors.
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 |
|---|---|---|
| Breast surgeryTraditional breast-conserving surgery, oncoplastic breast-conserving surgery or modified radical mastectomy | Procedure or surgery | Oncoplastic-BCS, Traditional BCS |
| Chemotherapy or endocrine therapy or Trastuzumab therapy | Drug | Oncoplastic-BCS, Traditional BCS |
| Radiation therapy | Radiation | Oncoplastic-BCS, Traditional BCS |
Primary outcome
Harvard/NSABP/RTOG breast cosmesis grading scale
Time frame: 5 years
5 secondary outcomes
Positivity rate of cavity margin
Time frame: Intraoperatively.
Local-recurrence free survival
Time frame: 5 years
Disease free survival
Time frame: 5 years
Breast Cancer Treatment Outcome Scale (BCTOS)
Time frame: 5 years
Morbidity
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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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.
Erwei Song, M.D. Ph.D. principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Fengxi Su, M.D. study director
Yat-sen Memorial Hospital, Sun Yat-sen University.
Questions about this trial
What is this clinical trial studying?
An observational study of Local Recurrence of Malignant Tumor of Breast, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 7 inclusion and 11 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: withdrawn, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harvard/NSABP/RTOG breast cosmesis grading scale (time frame: 5 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 3 Dec 2015.