AzTrials
AzTrials

Breast CancerNCT04792840

Skeletal Events of Hormonal Treatment and Radiotherapy in Patient With Breast Cacer

An observational study of Breast Cancer, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

ahmed g. hussain, residant contact

0201013736679

aghussain1993@gmial.com

hanan g. mostafa, prof dr contact

0201004082002

Mostafahanan36@yahoo.com

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.

  1. Skeletal events caused by hermonal treatment

    Hermonal treatment in breast Cancer patients may caused osteoporosis that can be measured by dexascan

    Measured: basline

  2. 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.

  1. First posted11 Mar 2021
  2. Study start1 Dec 2021 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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
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

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.

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