Female Breast CancerPhase 1NCT05755581
Efficacy of Neoadjuvant Endocrine Therapy Compared to Chemotherapy in Breast Cancer Patients
A Phase 1 study testing Hormonal Antineoplastics and Chemotherapy drug in people with Female Breast Cancer, run by Sohag University at 1 site in Egypt.
Trial summary
Eligible patients will be divided into two groups; one will receive neoadjuvant endocrine therapy and the other one will receive neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Breast Cancer
- What is being tested?
- Hormonal Antineoplastics and Chemotherapy drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Aug 2025
- Phase
- Phase 1
- 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
Who may be able to join
- Any histological type of invasive breast cancer. All grades of breast cancer (I, II, III). ER-positive and/or PR-positive, HER2-negative breast cancer. ER and/or PR level of positivity ≥34 % (score 4 according to modified Allred score).
- Clinical Stages: any T N1-3, or T2-4 any N, M0.
Who cannot join
- Hormone receptor positivity < 34%. inflammatory breast cancer Metastatic breast cancer. Recurrent breast cancer. Other malignancy. Unfit patients for chemotherapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
amal Ali
Sohag, 02
amal Ali, MD, 01010454426, amal_ali@med.sohag.edu.eg
About this study
Official title: Efficacy of Endocrine Therapy Compared to Chemotherapy as a Neoadjuvant Treatment for Patients With Hormone Receptor-positive and HER2-negative Breast Cancer.
Eligible patients will be divided into two groups; one will receive neoadjuvant endocrine therapy and the other one will receive neoadjuvant chemotherapy.
Read the detailed description
Patients will be randomized into two groups:
The first group (Arm A) will receive NCT; (Any approved Chemotherapy protocol by guidelines.
The second group(Arm B) will receive NET; GnRH analog Goserelin acetate 3.6 mg every 4 weeks with tamoxifen 20 mg daily for premenopausal patients or an aromatase inhibitor for postmenopausal patients.
- Before and during treatments (every 3 weeks for the NCT group, and every 4 weeks for the NET group), the clinical assessment will be performed for all patients.
- All patients will undergo breast magnetic resonance imaging (MRI) before the start of treatment, after 12 weeks (3 months) of treatment, and after the end of treatment before surgery.
- We will determine the objective tumor response with every measurement method and assess the response according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1.
- Treatment will be continued for 19-21 weeks before surgery for the chemotherapy group and 24 weeks for the endocrine therapy group.
- Ki-67 will be assessed using a sample of the core biopsy before treatment and a surgery specimen after treatment.
- Adverse events will be recorded at every patient visit and will be assessed according to the Common Terminology Criteria for Adverse Events Version 5.0.
- Surgery will be performed between the 24th and 26th week.
- Arm B Patients who will develop PD or SD after 6 months of treatment will be shifted to arm A.
The primary endpoint will be;
- The clinical response rate at the end of neoadjuvant treatment, as will be determined using caliper and MRI measurements.
- A clinical response included either a complete response (CR), a partial response (PR), Progressive Disease (PD), or Stable Disease (SD) according to the (RECIST) version 1.1.
Secondary endpoints will be;
- The rate of pathological complete response (pCR).
- The rate of breast conservation surgery.
- Ki-67 changes.
- The length of time to maximum response within a treatment period.
- The Adverse events associated with each treatment arm.
- Conditions
- Female Breast Cancer
- Being tested
- Hormonal Antineoplastics, Chemotherapy drug
- Keywords
- Neoadjuvant endocrine therapy ,neoadjuvant chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormonal AntineoplasticsDrug
the Neoadjuvant endocrine therapy group will receive neoadjuvant hormonal therapy.
Chemotherapy drugDrug
the Neoadjuvant chemotherapy group will receive neoadjuvant chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy group | Active comparator | Patients in this arm will receive neoadjuvant chemotherapy as usual Receives: Drug: Chemotherapy drug |
| Neoadjuvant endocrine therapy group | Active comparator | Patients in this group will receive neoadjuvant endocrine therapy Receives: Drug: Hormonal Antineoplastics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate
The primary endpoint will be; The clinical response rate at the end of neoadjuvant treatment, as will be determined using caliper and MRI measurements according to the (RECIST) version 1.1.
Measured: 6 months
Secondary outcomes (1)
pathological complete response
The rate of pathological complete response after surgery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Breast CancerStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into two groups: The first group (Arm A) will receive NCT; (Any approved Chemotherapy protocol by guidelines. The second group(Arm B) will receive NET; GnRH analog Goserelin acetate 3.6 mg every 4 weeks with tamoxifen 20 mg daily for premenopausal patients or an aromatase inhibitor for postmenopausal patients.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Ali Omar, Sohag University
- Investigators
- Amal Ali, MD, Principal investigator, Assistant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755581
- Sponsor's protocol ID
- Soh-Med-23-02-16
- Status last verified
- Feb 2023
- First submitted
- 15 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Endocrine Therapy Compared to Chemotherapy as a Neoadjuvant Treatment for Patients With Hormone Receptor-positive and HER2-negative Breast Cancer.
- ClinicalTrials.gov ID
- NCT05755581
- Acronym / sponsor ID
- Soh-Med-23-02-16
- Conditions
- Female Breast Cancer
- Keywords
- Neoadjuvant endocrine therapy ,neoadjuvant chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 6 Mar 2023 (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.
Eligible patients will be divided into two groups; one will receive neoadjuvant endocrine therapy and the other one will receive neoadjuvant chemotherapy.
Detailed description
Patients will be randomized into two groups:
The first group (Arm A) will receive NCT; (Any approved Chemotherapy protocol by guidelines.
The second group(Arm B) will receive NET; GnRH analog Goserelin acetate 3.6 mg every 4 weeks with tamoxifen 20 mg daily for premenopausal patients or an aromatase inhibitor for postmenopausal patients.
- Before and during treatments (every 3 weeks for the NCT group, and every 4 weeks for the NET group), the clinical assessment will be performed for all patients.
- All patients will undergo breast magnetic resonance imaging (MRI) before the start of treatment, after 12 weeks (3 months) of treatment, and after the end of treatment before surgery.
- We will determine the objective tumor response with every measurement method and assess the response according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1.
- Treatment will be continued for 19-21 weeks before surgery for the chemotherapy group and 24 weeks for the endocrine therapy group.
- Ki-67 will be assessed using a sample of the core biopsy before treatment and a surgery specimen after treatment.
- Adverse events will be recorded at every patient visit and will be assessed according to the Common Terminology Criteria for Adverse Events Version 5.0.
- Surgery will be performed between the 24th and 26th week.
- Arm B Patients who will develop PD or SD after 6 months of treatment will be shifted to arm A.
The primary endpoint will be;
- The clinical response rate at the end of neoadjuvant treatment, as will be determined using caliper and MRI measurements.
- A clinical response included either a complete response (CR), a partial response (PR), Progressive Disease (PD), or Stable Disease (SD) according to the (RECIST) version 1.1.
Secondary endpoints will be;
- The rate of pathological complete response (pCR).
- The rate of breast conservation surgery.
- Ki-67 changes.
- The length of time to maximum response within a treatment period.
- The Adverse events associated with each treatment arm.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized into two groups: The first group (Arm A) will receive NCT; (Any approved Chemotherapy protocol by guidelines. The second group(Arm B) will receive NET; GnRH analog Goserelin acetate 3.6 mg every 4 weeks with tamoxifen 20 mg daily for premenopausal patients or an aromatase inhibitor for postmenopausal patients.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy group | Active comparator | Drug: Chemotherapy drugPatients in this arm will receive neoadjuvant chemotherapy as usual |
| Neoadjuvant endocrine therapy group | Active comparator | Drug: Hormonal AntineoplasticsPatients in this group will receive neoadjuvant endocrine therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any histological type of invasive breast cancer. All grades of breast cancer (I, II, III). ER-positive and/or PR-positive, HER2-negative breast cancer. ER and/or PR level of positivity ≥34 % (score 4 according to modified Allred score).
- Clinical Stages: any T N1-3, or T2-4 any N, M0.
Key exclusion criteria (1 listed)
- Hormone receptor positivity < 34%. inflammatory breast cancer Metastatic breast cancer. Recurrent breast cancer. Other malignancy. Unfit patients for chemotherapy.
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 |
|---|---|---|
| Hormonal Antineoplasticsthe Neoadjuvant endocrine therapy group will receive neoadjuvant hormonal therapy. | Drug | Neoadjuvant endocrine therapy group |
| Chemotherapy drugthe Neoadjuvant chemotherapy group will receive neoadjuvant chemotherapy. | Drug | Neoadjuvant chemotherapy group |
Primary outcome
Clinical response rate
Time frame: 6 months
The primary endpoint will be; The clinical response rate at the end of neoadjuvant treatment, as will be determined using caliper and MRI measurements according to the (RECIST) version 1.1.
1 secondary outcome
pathological complete response
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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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.
Amal Ali, MD principal investigator
Assistant lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hormonal Antineoplastics and Chemotherapy drug in people with Female Breast Cancer, run by Sohag University 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 2 inclusion and 1 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 6 Mar 2023. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Amal Ali, MD (01010454426, amal_ali@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response rate (time frame: 6 months). 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 6 Mar 2023.