Breast Cancer FemaleNCT06631066
Effect of Neoadjuvant Chemoradiation on Pathologic Complete Response Rates in Locally Advanced Breast Cancer Patients
A study testing neoadjuvant chemoradiation in people with Breast Cancer Female, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This is a phase II randomized trial comparing pathologic complete response rates in locally advanced patients recieving either neoadjuvant chemotherapy or neoadjuvant chemoradiation. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- neoadjuvant chemoradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2021to 15 Jul 2024
- 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 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients.
- Age: 21 years or older.
- ECOG performance status (PS) score 0 to 2.
- Locally advanced tumors (stage IIIA or above) of any subtype.
- Early breast cancer of the HER2+ or TNBC subtype when:
- Node-negative, T2 or T3.
- Node-positive, any T stage.
Who cannot join
- Patients initially presenting with metastatic breast cancer.
- Patients unfit to receive planned regimen of treatment that had a poor PS (i.e.: PS 3 and 4).
- Inflammatory breast cancer (T4d) patients.
- Patients having contraindications to radiotherapy (e.g.: Pregnancy, history of previous chest wall, breast, or axillary irradiation)
- History of previous ipsilateral breast surgery.
- Comorbidities that would affect skin healing or integrity, like uncontrolled diabetes mellitus or active autoimmune collagen or vascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
This is a phase II randomized trial comparing pathologic complete response rates in locally advanced patients recieving either neoadjuvant chemotherapy or neoadjuvant chemoradiation.
Read the detailed description
A prospective randomized phase II trial, that enrolled locally advanced breast cancer patients who were randomized to recieve either neoadjuvant systemic treatment or neoadjuvant systemic treatment concurrently with radiotherapy. Surgery is done for all patients later on as indicated.
The pathological response rates between both groups will be compared, as well as surgical complications and acute radiation toxicity.
- Conditions
- Breast Cancer Female
- Being tested
- neoadjuvant chemoradiation
- Keywords
- preoperative radiotherapy, locally advanced breast cancer, pathologic response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemoradiationRadiation
Neoadjuvant chemoradiation will be prescribed as: 4 cycles of Adriamycin and Cyclophosphamide followed by radiotherapy concurrently with taxanes/ taxanes and carboplatin. followed by surgery as indicated.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant chemotherapy arm | No intervention | The patients in this arm will recieve neoadjuvant chemotherapy (with anti-her2 agents if indicated) according to the national guidelines. post systemic treatment imaging will be done to assess the response, followed by surgery as indicated. Adjuvant radiotherapy as well as hormonal or target therapy will be prescribed as indicated. Radiation therapy will be delivered in hypofractionated course (40.05 Gray over 15 fractions with boost to tumor bed 10 Gray over four fractions) to the breast/ chestwall as well as regional lymphatics. |
| Neoadjuvant chemoradiation arm | Experimental | The patients in this arm will recieve neoadjuvant chemotherapy with preoperative radiotherapy concurrently with taxanes. Surgery is done 6-8 weeks as indicated, followed by systemic treatment according to the guidelines. Receives: Radiation: neoadjuvant chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response rates
the pathologic response will be measured by the Randomized cancer burden (RCB) scoring system
Measured: 1 week postoperative
Secondary outcomes (1)
acute radiation toxicity
radiation therapy oncology group (RTOG) acute morbidity score
Measured: during radiation therapy: week 2,3,4. weekly after the end of radiation therapy for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start20 Oct 2021
- Primary completion10 Oct 2023
- Study completion15 Jul 2024
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 Cancer FemaleStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohammmed sayed, National Cancer Institute, Egypt
- Investigators
- Medhat El Sebaie, Professor, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631066
- Sponsor's protocol ID
- RO2109-30909
- Status last verified
- Oct 2024
- First submitted
- 13 Aug 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ward J, Ho K, Ike C, Wood SH, Thiruchelvam PTR, Khan AA, Leff DR. Pre-operative chemoradiotherapy followed by mastectomy and breast reconstruction-A systematic review of clinical, oncological, reconstructive and aesthetic outcomes. J Plast Reconstr Aesthet Surg. 2024 Sep;96:242-253. doi: 10.1016/j.bjps.2024.07.022. Epub 2024 Jul 15.
PubMed 39106546O' Halloran N, McVeigh T, Martin J, Keane M, Lowery A, Kerin M. Neoadjuvant chemoradiation and breast reconstruction: the potential for improved outcomes in the treatment of breast cancer. Ir J Med Sci. 2019 Feb;188(1):75-83. doi: 10.1007/s11845-018-1846-6. Epub 2018 Jun 14.
PubMed 29948462
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neoadjuvant Chemoradiation on Pathologic Complete Response Rates in Locally Advanced Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06631066
- Acronym / sponsor ID
- RO2109-30909
- Conditions
- Breast Cancer Female
- Keywords
- preoperative radiotherapy, locally advanced breast cancer, pathologic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 8 Oct 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.
This is a phase II randomized trial comparing pathologic complete response rates in locally advanced patients recieving either neoadjuvant chemotherapy or neoadjuvant chemoradiation.
Detailed description
A prospective randomized phase II trial, that enrolled locally advanced breast cancer patients who were randomized to recieve either neoadjuvant systemic treatment or neoadjuvant systemic treatment concurrently with radiotherapy. Surgery is done for all patients later on as indicated.
The pathological response rates between both groups will be compared, as well as surgical complications and acute radiation toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant chemotherapy arm | No intervention | –The patients in this arm will recieve neoadjuvant chemotherapy (with anti-her2 agents if indicated) according to the national guidelines. post systemic treatment imaging will be done to assess the response, followed by surgery as indicated. Adjuvant radiotherapy as well as hormonal or target therapy will be prescribed as indicated. Radiation therapy will be delivered in hypofractionated course (40.05 Gray over 15 fractions with boost to tumor bed 10 Gray over four fractions) to the breast/ chestwall as well as regional lymphatics. |
| Neoadjuvant chemoradiation arm | Experimental | Radiation: neoadjuvant chemoradiationThe patients in this arm will recieve neoadjuvant chemotherapy with preoperative radiotherapy concurrently with taxanes. Surgery is done 6-8 weeks as indicated, followed by systemic treatment according to the guidelines. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients.
- Age: 21 years or older.
- ECOG performance status (PS) score 0 to 2.
- Locally advanced tumors (stage IIIA or above) of any subtype.
- Early breast cancer of the HER2+ or TNBC subtype when:
Key exclusion criteria (6 listed)
- Patients initially presenting with metastatic breast cancer.
- Patients unfit to receive planned regimen of treatment that had a poor PS (i.e.: PS 3 and 4).
- Inflammatory breast cancer (T4d) patients.
- Patients having contraindications to radiotherapy (e.g.: Pregnancy, history of previous chest wall, breast, or axillary irradiation)
- History of previous ipsilateral breast surgery.
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 chemoradiationNeoadjuvant chemoradiation will be prescribed as: 4 cycles of Adriamycin and Cyclophosphamide followed by radiotherapy concurrently with taxanes/ taxanes and carboplatin. followed by surgery as indicated. | Radiation | Neoadjuvant chemoradiation arm |
Primary outcome
pathologic complete response rates
Time frame: 1 week postoperative
the pathologic response will be measured by the Randomized cancer burden (RCB) scoring system
1 secondary outcome
acute radiation toxicity
Time frame: during radiation therapy: week 2,3,4. weekly after the end of radiation therapy for 4 weeks
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 8 Oct 2024.
- Background: PubMed 39106546Ward J, Ho K, Ike C, Wood SH, Thiruchelvam PTR, Khan AA, Leff DR. Pre-operative chemoradiotherapy followed by mastectomy and breast reconstruction-A systematic review of clinical, oncological, reconstructive and aesthetic outcomes. J Plast Reconstr Aesthet Surg. 2024 Sep;96:242-253. doi: 10.1016/j.bjps.2024.07.022. Epub 2024 Jul 15.
- Background: PubMed 29948462O' Halloran N, McVeigh T, Martin J, Keane M, Lowery A, Kerin M. Neoadjuvant chemoradiation and breast reconstruction: the potential for improved outcomes in the treatment of breast cancer. Ir J Med Sci. 2019 Feb;188(1):75-83. doi: 10.1007/s11845-018-1846-6. Epub 2018 Jun 14.
- 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.
Medhat El Sebaie, Professor study chair
National Cancer Institute (NCI)
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 chemoradiation in people with Breast Cancer Female, run by National Cancer Institute, Egypt at 1 site in Egypt.
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 6 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 8 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 Egypt. 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?
pathologic complete response rates (time frame: 1 week postoperative). 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 NCT06631066, 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 8 Oct 2024.