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Eligible patients will be divided into two groups; one will receive neoadjuvant endocrine therapy and the other one will receive neoadjuvant chemotherapy.
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.
The primary endpoint will be;
Secondary endpoints will be;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant chemotherapy group | Active Comparator | Patients in this arm will receive neoadjuvant chemotherapy as usual |
|
| Neoadjuvant endocrine therapy group | Active Comparator | Patients in this group will receive neoadjuvant endocrine therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hormonal Antineoplastics | Drug | the Neoadjuvant endocrine therapy group will receive neoadjuvant hormonal therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response | The rate of pathological complete response after surgery. | 6 months |
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Inclusion Criteria:
Clinical Stages: any T N1-3, or T2-4 any N, M0.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amal Ali, MD | Contact | 01010454426 | amal_ali@med.sohag.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Amal Ali, MD | Assistant lecturer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| amal Ali | Sohag | 02 | Egypt |
|
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 25, 2025 | |
| Reset | Jul 11, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 25, 2025 | Jul 11, 2025 |
| ID | Term |
|---|---|
| D018931 | Antineoplastic Agents, Hormonal |
| ID | Term |
|---|---|
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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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.
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| Chemotherapy drug | Drug | the Neoadjuvant chemotherapy group will receive neoadjuvant chemotherapy. |
|