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Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Endometrial Neoplasms

Disease Attributes

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Bone Density Conservation Agents

Antineoplastic Agents

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Tamoxifen

Aromatase Inhibitors

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Antineoplastic Agents, Hormonal

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Estrogen Antagonists

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Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Enzyme Inhibitors

Patients with advanced stage or recurrent endometrial cancer treated with hormonal therapy

Hormonal therapy used for treatment in endometrial cancer patients

Hormonal Antineoplastics

Maartje Luijten, MD

Hanny Pijnenborg, MD PhD

Maartje Luijten

Hanny Pijnenborg

Roy Lalisang, MD PhD prof

Andrea Romano, MD PhD

Willem Jan Van Weelden, MD

The PROMOTE study aims at optimising use of hormonal therapy in advanced stage and recurrent endometrial cancer analysing tumor tissue taken before start of hormonal therapy

There is limited consensus about the position of hormonal treatment in advanced and metastatic endometrial carcinoma (EC). This is due to lack of good quality data on patient selection, and predictive biomarkers. Consequently, consideration of hormonal therapy is subjected to personal experience of the treating physician, rather than on refined clinical and up-to-date molecular criteria. Hormonal therapy has limited side-effects, and is better tolerated than systematic chemotherapy. Since EC patients are often elderly women with comorbidities, more effective and less aggressive treatment options are needed, underlining the urgency of an explorative study on this topic.

Endometrial cancer is the most common malignancy of the female genital tract in developed countries, with increasing incidence due to obesity and increased life expectancy. Most patients are diagnosed at an early stage, and have a favourable prognosis with surgery alone. Yet, 20% of the patients present with advanced or metastatic EC and have a poor outcome even with systemic treatment. Response rate of chemotherapy in advanced or metastatic EC is 30-60%, dependent of previous chemotherapy, with a progression free survival (PFS) of 3-14 months and 40% treatment related morbidity. In comparison, response to hormonal therapy is 20%-40%, with side effects in less than 5%. The overall PFS is 3 months, yet for those who respond the PFS can be up to several years.

To improve selective use of hormonal therapy in EC by evaluating applied hormonal therapy in advanced and metastatic EC and correlate response to molecular tumour analysis and translate this knowledge after validation into clinical practice

Tumor samples originating from before start of hormonal therapy

PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer

Complete or partial response according to RECIST criteria

Interval from start of hormonal therapy to progressive disease or death

Complete or partial response or stable disease according to RECIST criteria

Health-related quality of life during hormonal therapy as tested with the validated EORTC-QLQ-C30 and EORTC-QLQ-EN24 quality-of-life scales at start of hormonal therapy and 6 months after start therapy

Haukeland University Hospital

Maastricht University Medical Center

Brno University Hospital

Holycross Cancer Center Kielce

Medical University of Lublin

Hospital del Mar

Hospital Vall d'Hebron

Royal Cornwall Hospitals Trust

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

The Netherlands Cancer Institute

Canisius-Wilhelmina Hospital

Catharina Ziekenhuis Eindhoven

Erasmus Medical Center

Leiden University Medical Center

Radboud University Medical Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients in this arm will receive neoadjuvant chemotherapy as usual

Patients in this group will receive neoadjuvant endocrine therapy

the Neoadjuvant endocrine therapy group will receive neoadjuvant hormonal therapy.

the Neoadjuvant chemotherapy group will receive neoadjuvant chemotherapy.

Chemotherapy drug

Amal Ali, MD

amal Ali, MD

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.

* 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.

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.

Efficacy of Neoadjuvant Endocrine Therapy Compared to Chemotherapy in Breast Cancer Patients

Efficacy of Endocrine Therapy Compared to Chemotherapy as a Neoadjuvant Treatment for Patients With Hormone Receptor-positive and HER2-negative Breast Cancer.

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.

The rate of pathological complete response after surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer	NCT03621904	Endometrial Can... Endometrial Can... Endometrial Can...	Hormonal Antine...	18 Years - 110 Years	Radboud University Medical Center
PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer	NCT03621904	Endometrial Can... Endometrial Can... Endometrial Can...	Hormonal Antine...	18 Years - 110 Years	Radboud University Medical Center
Efficacy of Neoadjuvant Endocrine Therapy Compared to Chemotherapy in Breast Cancer Patients	NCT05755581	Female Breast C...	Hormonal Antine... Chemotherapy dr...	18 Years -	Sohag University
PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer	NCT03621904	Endometrial Can... Endometrial Can... Endometrial Can...	Hormonal Antine...	18 Years - 110 Years	Radboud University Medical Center
Efficacy of Neoadjuvant Endocrine Therapy Compared to Chemotherapy in Breast Cancer Patients	NCT05755581	Female Breast C...	Hormonal Antine... Chemotherapy dr...	18 Years -	Sohag University

Spots Global Cancer Trial Database for hormonal antineoplastics