Breast CancerNCT04792840
Skeletal Events of Hormonal Treatment and Radiotherapy in Patient With Breast Cacer
An observational study of Breast Cancer, run by Assiut University.
Trial summary
study of lymphedema and skeletal events in breast cacer patient receiving adjuvant hormonal therapy and radiothearpy Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Femara Pill
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to Dec 2021
- How long will I take part?
- 24 Months
- 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: older patient with breat cancer who receives hormonal treatment and radiothearpy
Who may be able to join
- Postmenopausal patients with positive diagnosis of stage 1-3 breast cancer and planned AI (anastrazole, letrozole) adjuvant treatment will be included in the study.
- Patients without known osteoporosis will included in the study, and before AI treatment began.
- Conventional RT course must be completed (50 Gy/25 fractions, 2 Gy/fraction, 5 days/week).
- Patients continue to receive adjuvant hormonal treatment (aromatase inhibitors) or adjuvant target therapy (trastuzumab) while monitoring late toxicities
Who cannot join
- Male patients
- Metastatic disease at presentation
- No definitive surgery
- Carcinoma in situ or other rare tumors of the breast as phyllodes tumors.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Lymphedema and Skeletal Events in Older Patients Receiving Adjuvant Hormonal and Radiotherarpy in Breast Cancer
study of lymphedema and skeletal events in breast cacer patient receiving adjuvant hormonal therapy and radiothearpy
Read the detailed description
In the United States, it is estimated that there are more than 3.8 million living women has a history of invasive breast cancer, and 268,600 women will be newly diagnosed in 2019. Sixty-four percent of breast cancer survivors (more than 2.4 million women) are ≥ 65 years, whereas 7% are aged younger than 50 years 1.
The most common treatment of early stage (stage I or II) breast cancer is breast-conserving surgery (BCS) with adjuvant radiation therapy (49%) and 34% of patients undergo mastectomy. In contrary, more than two-thirds (68%) of patients with stage III disease undergo mastectomy and most of them receive adjuvant chemotherapy 2.
Some of the most debilitating morbidity after surgery and radiotherapy for breast cancer is related to treatment of the axilla. This includes persistent arm lymphoedema, impaired shoulder mobility and brachial plexopathy. Other exogenous factors have an influence on the risk of radiotherapy-related morbidity as patients' age and obesity 3.
Lymphedema of the arm occurs in 19.9% of women who undergo axillary lymph node dissection and in 5.6% of women who have a sentinel lymph node biopsy 4. Irradiation of the regional lymph nodes may increase the risk, especially among patients receiving axillary lymph node dissection 5.
Early diagnosis of lymphedema is important for optimizing its treatment and preventing its progression 6. Some forms of cancer rehabilitation may reduce the risk and lessen the severity of this condition 7, 8.
Treatment with adjuvant aromatase inhibitors (AI), which is generally reserved for postmenopausal women, can cause osteoporosis 9.
Osteoporosis, a process of bone mineral density (BMD) reduction, is accelerated by estrogen deficiency in postmeno¬pausal women. Tamoxifen reduces BMD in premenopausal women, while promotes bone formation in postmenopausal patients. On the other hand, adjuvant aromatase inhibitors (AIs) therapy enhances the BMD decrease to about 2.5% per year, due to a long lasting significant deprivation of circula¬tory and tissue estrogens 10. In the bone companion study of the MA.17 trial, patients treated with anastrozole reported a significant decreases in BMD (~4%), compared to those treated with tamoxifen 11.
Dual energies' X ray absorptiometry (DXA) scan is the current validated 'gold standard' for the diagnosis of osteoporosis, fracture risk estimation and follow up of anti osteoporotic treatment 12-14, since it is non invasive, simple, precise, fast, less expensive than other imaging techniques, including computed tomography and magnetic resonance imaging, and more sensitive than quantitative ultrasound (QUS) 15.
- Conditions
- Breast Cancer
- Being tested
- Femara Pill
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femara PillDrug
Also called radiothearpy
study effect on bone
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal events caused by hermonal treatment
Hermonal treatment in breast Cancer patients may caused osteoporosis that can be measured by dexascan
Measured: basline
Radiotherapy and arm edema
Radiothearpy on axilla my increase arm edema in breast cancer patients measuredvby arm circumference in centimeters
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Dec 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed gamal hussein, Assiut University
- Investigators
- hanan g. mostafa, prof dr, Study director, Assiut Universitymohammed a. mohmmed, dr, Study director, Assiut Universitymaha s. el naggar, dr, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792840
- Sponsor's protocol ID
- events in breast cancer
- Status last verified
- Mar 2021
- First submitted
- 25 Nov 2020
- Last updated
- 11 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphedema and Skeletal Events in Older Patients Receiving Adjuvant Hormonal and Radiotherarpy in Breast Cancer
- ClinicalTrials.gov ID
- NCT04792840
- Acronym / sponsor ID
- events in breast cancer
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 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.
study of lymphedema and skeletal events in breast cacer patient receiving adjuvant hormonal therapy and radiothearpy
Detailed description
In the United States, it is estimated that there are more than 3.8 million living women has a history of invasive breast cancer, and 268,600 women will be newly diagnosed in 2019. Sixty-four percent of breast cancer survivors (more than 2.4 million women) are ≥ 65 years, whereas 7% are aged younger than 50 years 1.
The most common treatment of early stage (stage I or II) breast cancer is breast-conserving surgery (BCS) with adjuvant radiation therapy (49%) and 34% of patients undergo mastectomy. In contrary, more than two-thirds (68%) of patients with stage III disease undergo mastectomy and most of them receive adjuvant chemotherapy 2.
Some of the most debilitating morbidity after surgery and radiotherapy for breast cancer is related to treatment of the axilla. This includes persistent arm lymphoedema, impaired shoulder mobility and brachial plexopathy. Other exogenous factors have an influence on the risk of radiotherapy-related morbidity as patients' age and obesity 3.
Lymphedema of the arm occurs in 19.9% of women who undergo axillary lymph node dissection and in 5.6% of women who have a sentinel lymph node biopsy 4. Irradiation of the regional lymph nodes may increase the risk, especially among patients receiving axillary lymph node dissection 5.
Early diagnosis of lymphedema is important for optimizing its treatment and preventing its progression 6. Some forms of cancer rehabilitation may reduce the risk and lessen the severity of this condition 7, 8.
Treatment with adjuvant aromatase inhibitors (AI), which is generally reserved for postmenopausal women, can cause osteoporosis 9.
Osteoporosis, a process of bone mineral density (BMD) reduction, is accelerated by estrogen deficiency in postmeno¬pausal women. Tamoxifen reduces BMD in premenopausal women, while promotes bone formation in postmenopausal patients. On the other hand, adjuvant aromatase inhibitors (AIs) therapy enhances the BMD decrease to about 2.5% per year, due to a long lasting significant deprivation of circula¬tory and tissue estrogens 10. In the bone companion study of the MA.17 trial, patients treated with anastrozole reported a significant decreases in BMD (~4%), compared to those treated with tamoxifen 11.
Dual energies' X ray absorptiometry (DXA) scan is the current validated 'gold standard' for the diagnosis of osteoporosis, fracture risk estimation and follow up of anti osteoporotic treatment 12-14, since it is non invasive, simple, precise, fast, less expensive than other imaging techniques, including computed tomography and magnetic resonance imaging, and more sensitive than quantitative ultrasound (QUS) 15.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- older patient with breat cancer who receives hormonal treatment and radiothearpy
Key inclusion criteria (4 listed)
- Postmenopausal patients with positive diagnosis of stage 1-3 breast cancer and planned AI (anastrazole, letrozole) adjuvant treatment will be included in the study.
- Patients without known osteoporosis will included in the study, and before AI treatment began.
- Conventional RT course must be completed (50 Gy/25 fractions, 2 Gy/fraction, 5 days/week).
- Patients continue to receive adjuvant hormonal treatment (aromatase inhibitors) or adjuvant target therapy (trastuzumab) while monitoring late toxicities
Key exclusion criteria (4 listed)
- Male patients
- Metastatic disease at presentation
- No definitive surgery
- Carcinoma in situ or other rare tumors of the breast as phyllodes 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 |
|---|---|---|
| Femara PillAlso: radiothearpystudy effect on bone | Drug | – |
Primary outcome
Skeletal events caused by hermonal treatment
Time frame: basline
Hermonal treatment in breast Cancer patients may caused osteoporosis that can be measured by dexascan
Radiotherapy and arm edema
Time frame: Baseline
Radiothearpy on axilla my increase arm edema in breast cancer patients measuredvby arm circumference in centimeters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
hanan g. mostafa, prof dr study director
Assiut University
mohammed a. mohmmed, dr study director
Assiut University
maha s. el naggar, dr study director
Assiut University
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 4 inclusion and 4 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 11 Mar 2021. 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?
Contact ahmed g. hussain, residant (0201013736679, aghussain1993@gmial.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal events caused by hermonal treatment (time frame: basline). 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 11 Mar 2021.