Breast NeoplasmsNCT05274594
Efficacy of Preoperative Radiotherapy for Non-responder Patients After Neoadjuvant Chemotherapy
An observational study of Breast Neoplasms and Radiotherapy; Complications, run by Istanbul Breast Society at 1 site in Turkey (Türkiye).
Trial summary
Neoadjuvant chemotherapy (NACT) is widely used for locally advanced breast cancer cases. As the key factor is to achieve pathologic complete response (pCR), several physicians tried administering radiotherapy before surgery to increase response rates. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms, Radiotherapy; Complications, Survivorship
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 1 Jan 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients admitted to Istanbul Faculty of Medicine Breast Unit
Who may be able to join
- American Joint Committee on Cancer (AJCC) clinical T1-3
- Biopsy proven N+
- Non-metastatic (M0)
- Patients who are planned to receive adjuvant radiotherapy at initial evaluation
- Patients who are candidate for neoadjuvant chemotherapy
- Patients who did not achieved clinical complete response after neoadjuvant chemotherapy
Who cannot join
- AJCC clinical T4
- AJCC Clinical N-
- AJCC Clinical M1
- Patients who achieved clinical complete response after neoadjuvant chemotherapy
- Patients who did not consent to have neoadjuvant radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Preoperative Radiotherapy for Non-responder Patients After Neoadjuvant Chemotherapy: a Pilot Observational Study
Neoadjuvant chemotherapy (NACT) is widely used for locally advanced breast cancer cases. As the key factor is to achieve pathologic complete response (pCR), several physicians tried administering radiotherapy before surgery to increase response rates. In this single center observational cohort study, we aim to present the initial results as complete response rates and complication rates of additional neoadjuvant radiotherapy (NART) after NACT.
Read the detailed description
Patients who received NACT were enrolled on the study depending on their order of admission. NACT regimen was 4 cycles of anthracycline and cyclophosphamide with 12 cycles of taxane based regimen. Trastuzumab for 12 monhts was also added if pathologically human epidermal growth factor receptor 2 (HER2+). This protocol was the same as planned for postoperative protocol and it was decided by the medical oncologist of the patient. Pathologic complete response (pCR) was defined as no residual invasive or in-situ tumor in the final pathology following neoadjuvant treatments. Clinical complete response (cCR) was defined as no sign of residual tumor mass and The Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria's were used to determine cCR. Patients were evaluated for clinical response between 4 and 6 weeks after the end of last NART. We waited as long as the NART period for clinical response evaluation of the cases.
Every patient was discussed in the preoperative multidisciplinary breast surgical oncology meeting before and after neoadjuvant treatment. The method of surgery was discussed in these meetings by a group of expert breast surgeons, plastic and reconstructive surgeons, radiation oncologists, medical oncologists, and radiologists. Patients were specifically evaluated for breast conservation, mastectomy or mastectomy with reconstruction. Likewise, the method of axillary surgery also discussed in these meetings. Indications for mastectomy were initially multi-centric tumors, large tumor volume relative to breast volume that is not allowing a good cosmetic result, patients with breast cancer related gene mutations, extensive in-situ component. Reconstruction with implant was also recommended to all mastectomy patients.
Radiotherapy was delivered via 4-6 megavoltage (MV) X-ray beam energies and Intensity Modulated Radiation Therapy (IMRT) or Volumetric Modulated Arc Therapy (VMAT) or forward planning IMRT (field in field - FinF) treatment techniques. NART was planned as 42.5 gray (Gy) in 16 fractions (with 10 Gy in 5 fractions sequential boost doses) or 50 Gy in 25 fractions (with 10 Gy in 5 fractions sequential boost doses) or 50.4 Gy in 28 fractions (with 59.9 Gy in 28 fractions simultaneous integrated boost doses) the whole breast irradiation plus nodal irradiation (including supraclavicular and axillary lymph nodes - Level I, II, III), if breast conserving surgery (BCS) is planned. If mastectomy is scheduled following NART, irradiation was planned with the same treatment volumes (the whole breast irradiation plus nodal irradiation) and doses like in BCS, but boost dose delivery was left to the radiation oncologist's preference. Radiotherapy to the mammary internal lymph nodes was delivered upon discretion of the radiation oncologist, and according to the tumor characteristics such as clinical stage or tumor location. Surgery was planned six weeks after the end of NART.
- Being tested
- Radiotherapy
- Keywords
- breast neoplasm, radiotherapy, neoadjuvant therapy, chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Patients who are candidate for radiotherapy and received neoadjuvant chemotherapy for breast cancer were evaluated after neoadjuvant chemotherapy. Cases that do not have clinical response received radiotherapy before surgery in order to increase complete response.
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate following neoadjuvant radiotherapy
Additional complete response effect of neoadjuvant radiotherapy for non-clinical complete responder patients following neoadjuvant chemotherapy.
Measured: Up to 4 weeks after definitive surgery
Secondary outcomes (1)
Radiotherapy toxicity
Toxicity degree of neoadjuvant radiotherapy
Measured: During the first Four weeks after the last dose of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Jan 2017
- Primary completion1 Jan 2020
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Breast Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmut Müslümanoğlu, Prof. Dr., Principal investigator, MD,FEBS,FACS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274594
- Sponsor's protocol ID
- IstanbulBreast-22_01
- Status last verified
- Mar 2022
- First submitted
- 30 Jan 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozkurt E, Sakai T, Wong SM, Tukenmez M, Golshan M. Survival Outcomes for Patients With Clinical Complete Response After Neoadjuvant Chemotherapy: Is Omitting Surgery an Option? Ann Surg Oncol. 2019 Oct;26(10):3260-3268. doi: 10.1245/s10434-019-07534-1. Epub 2019 Jul 24.
PubMed 31342356Bollet MA, Belin L, Reyal F, Campana F, Dendale R, Kirova YM, Thibault F, Dieras V, Sigal-Zafrani B, Fourquet A. Preoperative radio-chemotherapy in early breast cancer patients: long-term results of a phase II trial. Radiother Oncol. 2012 Jan;102(1):82-8. doi: 10.1016/j.radonc.2011.08.017. Epub 2011 Sep 8.
PubMed 21907436
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preoperative Radiotherapy for Non-responder Patients After Neoadjuvant Chemotherapy: a Pilot Observational Study
- ClinicalTrials.gov ID
- NCT05274594
- Acronym / sponsor ID
- IstanbulBreast-22_01
- Keywords
- breast neoplasm, radiotherapy, neoadjuvant therapy, chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Istanbul Breast SocietyUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 10 Mar 2022 (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.
Neoadjuvant chemotherapy (NACT) is widely used for locally advanced breast cancer cases. As the key factor is to achieve pathologic complete response (pCR), several physicians tried administering radiotherapy before surgery to increase response rates. In this single center observational cohort study, we aim to present the initial results as complete response rates and complication rates of additional neoadjuvant radiotherapy (NART) after NACT.
Detailed description
Patients who received NACT were enrolled on the study depending on their order of admission. NACT regimen was 4 cycles of anthracycline and cyclophosphamide with 12 cycles of taxane based regimen. Trastuzumab for 12 monhts was also added if pathologically human epidermal growth factor receptor 2 (HER2+). This protocol was the same as planned for postoperative protocol and it was decided by the medical oncologist of the patient. Pathologic complete response (pCR) was defined as no residual invasive or in-situ tumor in the final pathology following neoadjuvant treatments. Clinical complete response (cCR) was defined as no sign of residual tumor mass and The Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria's were used to determine cCR. Patients were evaluated for clinical response between 4 and 6 weeks after the end of last NART. We waited as long as the NART period for clinical response evaluation of the cases.
Every patient was discussed in the preoperative multidisciplinary breast surgical oncology meeting before and after neoadjuvant treatment. The method of surgery was discussed in these meetings by a group of expert breast surgeons, plastic and reconstructive surgeons, radiation oncologists, medical oncologists, and radiologists. Patients were specifically evaluated for breast conservation, mastectomy or mastectomy with reconstruction. Likewise, the method of axillary surgery also discussed in these meetings. Indications for mastectomy were initially multi-centric tumors, large tumor volume relative to breast volume that is not allowing a good cosmetic result, patients with breast cancer related gene mutations, extensive in-situ component. Reconstruction with implant was also recommended to all mastectomy patients.
Radiotherapy was delivered via 4-6 megavoltage (MV) X-ray beam energies and Intensity Modulated Radiation Therapy (IMRT) or Volumetric Modulated Arc Therapy (VMAT) or forward planning IMRT (field in field - FinF) treatment techniques. NART was planned as 42.5 gray (Gy) in 16 fractions (with 10 Gy in 5 fractions sequential boost doses) or 50 Gy in 25 fractions (with 10 Gy in 5 fractions sequential boost doses) or 50.4 Gy in 28 fractions (with 59.9 Gy in 28 fractions simultaneous integrated boost doses) the whole breast irradiation plus nodal irradiation (including supraclavicular and axillary lymph nodes - Level I, II, III), if breast conserving surgery (BCS) is planned. If mastectomy is scheduled following NART, irradiation was planned with the same treatment volumes (the whole breast irradiation plus nodal irradiation) and doses like in BCS, but boost dose delivery was left to the radiation oncologist's preference. Radiotherapy to the mammary internal lymph nodes was delivered upon discretion of the radiation oncologist, and according to the tumor characteristics such as clinical stage or tumor location. Surgery was planned six weeks after the end of NART.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients admitted to Istanbul Faculty of Medicine Breast Unit
Key inclusion criteria (6 listed)
- American Joint Committee on Cancer (AJCC) clinical T1-3
- Biopsy proven N+
- Non-metastatic (M0)
- Patients who are planned to receive adjuvant radiotherapy at initial evaluation
- Patients who are candidate for neoadjuvant chemotherapy
Key exclusion criteria (5 listed)
- AJCC clinical T4
- AJCC Clinical N-
- AJCC Clinical M1
- Patients who achieved clinical complete response after neoadjuvant chemotherapy
- Patients who did not consent to have neoadjuvant radiotherapy
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 |
|---|---|---|
| RadiotherapyPatients who are candidate for radiotherapy and received neoadjuvant chemotherapy for breast cancer were evaluated after neoadjuvant chemotherapy. Cases that do not have clinical response received radiotherapy before surgery in order to increase complete response. | Radiation | – |
Primary outcome
Complete response rate following neoadjuvant radiotherapy
Time frame: Up to 4 weeks after definitive surgery
Additional complete response effect of neoadjuvant radiotherapy for non-clinical complete responder patients following neoadjuvant chemotherapy.
1 secondary outcome
Radiotherapy toxicity
Time frame: During the first Four weeks after the last dose of radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Background: PubMed 31342356Ozkurt E, Sakai T, Wong SM, Tukenmez M, Golshan M. Survival Outcomes for Patients With Clinical Complete Response After Neoadjuvant Chemotherapy: Is Omitting Surgery an Option? Ann Surg Oncol. 2019 Oct;26(10):3260-3268. doi: 10.1245/s10434-019-07534-1. Epub 2019 Jul 24.
- Results publication: PubMed 21907436Bollet MA, Belin L, Reyal F, Campana F, Dendale R, Kirova YM, Thibault F, Dieras V, Sigal-Zafrani B, Fourquet A. Preoperative radio-chemotherapy in early breast cancer patients: long-term results of a phase II trial. Radiother Oncol. 2012 Jan;102(1):82-8. doi: 10.1016/j.radonc.2011.08.017. Epub 2011 Sep 8.
- 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.
Mahmut Müslümanoğlu, Prof. Dr. principal investigator
MD,FEBS,FACS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Radiotherapy; Complications, run by Istanbul Breast Society at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 10 Mar 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete response rate following neoadjuvant radiotherapy (time frame: Up to 4 weeks after definitive surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05274594, which also lists 2 linked publications.
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 10 Mar 2022.