Breast CancerNCT04809844
Concurrent Paclitaxel and Radiotherapy After Adjuvant Doxorubicin and Cyclophosphamide for Stage 2 or 3 Breast Cancer
An observational study of Breast Cancer, run by Assiut University.
Trial summary
The aim of this study is Evaluation of the efficacy \& toxicity of concurrent paclitaxel and breast radiotherapy and assesment of overall survival \& progression free survival Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Concurrent chemoradiation
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Dec 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study will include female patients with stage II-lll breast cancer who underwent conservative breast surgery \& modified radical mastectomy
Who may be able to join
- • This study will include women aged 18 years \&older.
- patients must be histologically diagnosed with breast cancer (ductal \& others).
- patients who underwent conservative breast surgery \& modified radical mastectomy.
- patients with stage ll\&lll breast cancer.
- patients who received (AC) as adjuvant treatment .
Who cannot join
- patients with stage 1 or 4 breast cancer.
- patients received adjuvant chemotherapy rather than (AC) .
- patients with prior irradiation with thoracic region .
- pregnancy or lactation .
- patient with serious comorbid disease such as chronic obstructive pulmonary disease .
About this study
Official title: Retrospective Study of Concurrent Paclitaxel and Radiation Therapy After Adjuvant Doxorubicin and Cyclophosphamide Chemotherapy for Stage 2 or 3 Breast Cancer
The aim of this study is Evaluation of the efficacy \& toxicity of concurrent paclitaxel and breast radiotherapy and assesment of overall survival \& progression free survival
Read the detailed description
Over the recent years , breast cancer remains the most common cancer in women in the world . With nearly 107 Million new Cases diagnosed in 2012 (second most common cancer over all) . this represent about 12 % of all new cancer cases and 25 % of all cancers in women . By contrast the mortality rate has declined dramatically since the introduction of adjuvant systemic therapy \& radiation therapy, which are now used extensively for their established benefit in local (radiotherapy ) ,survival without metastasis (chemotherapy) and overall survival of both of them . However , the optimal sequence of chemotherapy \& radiotherapy remain controversial three sequence were investigated:
- Delivering all radiotherapy first .
- A " Sandwich " approach .
- Delivering all chemotherapy first . Observational studies have suggested that delaying initiation of chemotherapy increase the incidence of distant metastasis \& delaying the initiation therapy more than 6 months after breast cancer diagnosis might increase risk of local regional recurrence . Concurrent chemoradiation therapy has an advantage of shortening the duration of therapy , allowing radiotherapy \& chemotherapy to start temporally and potentially improving local control via radiation sensitizing effect of chemotherapy.The feasibility of concurrent radiotherapy with taxane, which constitute a standard treatment used as adjuvant therapy has been evaluated in stage II,III breast cancer. Taxane Promote stabilization of microtubules causing cell cycle arrest in G2/M junction and serve as radio sensitizing agents.In a prospective study using Paclitaxel \& radiotherapy concurrently Paclitaxel given every 3 weeks for 4 cycles the authors concluded that Concurrent chemoradiation therapy improve local control with acceptable toxicity.
- Conditions
- Breast Cancer
- Being tested
- Concurrent chemoradiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent chemoradiationOther
concurrent Paclitaxel and radiation therapy after Adjuvant doxorubicin and Cyclophosphamide chemotherapy for stage ll or lll breast cancer .
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity of concurrent paclitaxel & breast radiotherapy such as acute skin toxicities .
Acute skin toxicities will be graded by using a scale ranging from 0-4 where 0= no change ,1= follicular, faint or dull erythema/epilation/ dry desquamation , 2= tender or bright erythema , 3= confluent moist desquamation , pitting edema , 4= ulceration , hemorrhage , necrosis .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study startSep 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Gamal Boraey, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809844
- Sponsor's protocol ID
- Breast cancer in females
- Status last verified
- Oct 2022
- First submitted
- 13 Mar 2021
- Last updated
- 18 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ghoncheh M, Pournamdar Z, Salehiniya H. Incidence and Mortality and Epidemiology of Breast Cancer in the World. Asian Pac J Cancer Prev. 2016;17(S3):43-6. doi: 10.7314/apjcp.2016.17.s3.43.
PubMed 27165206Olivotto IA, Bajdik CD, Plenderleith IH, Coppin CM, Gelmon KA, Jackson SM, Ragaz J, Wilson KS, Worth A. Adjuvant systemic therapy and survival after breast cancer. N Engl J Med. 1994 Mar 24;330(12):805-10. doi: 10.1056/NEJM199403243301201.
PubMed 8114832Abal M, Andreu JM, Barasoain I. Taxanes: microtubule and centrosome targets, and cell cycle dependent mechanisms of action. Curr Cancer Drug Targets. 2003 Jun;3(3):193-203. doi: 10.2174/1568009033481967.
PubMed 12769688Ali Hassan A, Ibrahim NY, Jassen MAR. Concurrent Paclitaxel and Radiotherapy for Node Positive Breast Cancer. Gulf J Oncolog. 2019 Jan;1(29):14-21.
PubMed 30956192
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Concurrent Paclitaxel and Radiation Therapy After Adjuvant Doxorubicin and Cyclophosphamide Chemotherapy for Stage 2 or 3 Breast Cancer
- ClinicalTrials.gov ID
- NCT04809844
- Acronym / sponsor ID
- Breast cancer in females
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Mar 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.
The aim of this study is Evaluation of the efficacy \& toxicity of concurrent paclitaxel and breast radiotherapy and assesment of overall survival \& progression free survival
Detailed description
Over the recent years , breast cancer remains the most common cancer in women in the world . With nearly 107 Million new Cases diagnosed in 2012 (second most common cancer over all) . this represent about 12 % of all new cancer cases and 25 % of all cancers in women . By contrast the mortality rate has declined dramatically since the introduction of adjuvant systemic therapy \& radiation therapy, which are now used extensively for their established benefit in local (radiotherapy ) ,survival without metastasis (chemotherapy) and overall survival of both of them . However , the optimal sequence of chemotherapy \& radiotherapy remain controversial three sequence were investigated:
- Delivering all radiotherapy first .
- A " Sandwich " approach .
- Delivering all chemotherapy first . Observational studies have suggested that delaying initiation of chemotherapy increase the incidence of distant metastasis \& delaying the initiation therapy more than 6 months after breast cancer diagnosis might increase risk of local regional recurrence . Concurrent chemoradiation therapy has an advantage of shortening the duration of therapy , allowing radiotherapy \& chemotherapy to start temporally and potentially improving local control via radiation sensitizing effect of chemotherapy.The feasibility of concurrent radiotherapy with taxane, which constitute a standard treatment used as adjuvant therapy has been evaluated in stage II,III breast cancer. Taxane Promote stabilization of microtubules causing cell cycle arrest in G2/M junction and serve as radio sensitizing agents.In a prospective study using Paclitaxel \& radiotherapy concurrently Paclitaxel given every 3 weeks for 4 cycles the authors concluded that Concurrent chemoradiation therapy improve local control with acceptable toxicity.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include female patients with stage II-lll breast cancer who underwent conservative breast surgery \& modified radical mastectomy
Key inclusion criteria (5 listed)
- • This study will include women aged 18 years \&older.
- patients must be histologically diagnosed with breast cancer (ductal \& others).
- patients who underwent conservative breast surgery \& modified radical mastectomy.
- patients with stage ll\&lll breast cancer.
- patients who received (AC) as adjuvant treatment .
Key exclusion criteria (5 listed)
- patients with stage 1 or 4 breast cancer.
- patients received adjuvant chemotherapy rather than (AC) .
- patients with prior irradiation with thoracic region .
- pregnancy or lactation .
- patient with serious comorbid disease such as chronic obstructive pulmonary disease .
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 |
|---|---|---|
| Concurrent chemoradiationconcurrent Paclitaxel and radiation therapy after Adjuvant doxorubicin and Cyclophosphamide chemotherapy for stage ll or lll breast cancer . | Other | – |
Primary outcome
Toxicity of concurrent paclitaxel & breast radiotherapy such as acute skin toxicities .
Time frame: baseline
Acute skin toxicities will be graded by using a scale ranging from 0-4 where 0= no change ,1= follicular, faint or dull erythema/epilation/ dry desquamation , 2= tender or bright erythema , 3= confluent moist desquamation , pitting edema , 4= ulceration , hemorrhage , necrosis .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Background: PubMed 27165206Ghoncheh M, Pournamdar Z, Salehiniya H. Incidence and Mortality and Epidemiology of Breast Cancer in the World. Asian Pac J Cancer Prev. 2016;17(S3):43-6. doi: 10.7314/apjcp.2016.17.s3.43.
- Background: PubMed 8114832Olivotto IA, Bajdik CD, Plenderleith IH, Coppin CM, Gelmon KA, Jackson SM, Ragaz J, Wilson KS, Worth A. Adjuvant systemic therapy and survival after breast cancer. N Engl J Med. 1994 Mar 24;330(12):805-10. doi: 10.1056/NEJM199403243301201.
- Background: PubMed 12769688Abal M, Andreu JM, Barasoain I. Taxanes: microtubule and centrosome targets, and cell cycle dependent mechanisms of action. Curr Cancer Drug Targets. 2003 Jun;3(3):193-203. doi: 10.2174/1568009033481967.
- Background: PubMed 30956192Ali Hassan A, Ibrahim NY, Jassen MAR. Concurrent Paclitaxel and Radiotherapy for Node Positive Breast Cancer. Gulf J Oncolog. 2019 Jan;1(29):14-21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assiut 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 5 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: status not confirmed, as of the sponsor's last update on 18 Oct 2022. 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?
Results are not available in the source record.
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?
Toxicity of concurrent paclitaxel & breast radiotherapy such as acute skin toxicities . (time frame: baseline). 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 NCT04809844, which also lists 4 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 18 Oct 2022.