A clinical trial to study the effects of two drugs, palbociclib & anastrozole in endometrial cancer patients.

Phase 2

Conditions: Health Condition 1: C541- Malignant neoplasm of endometrium

Registration Number: CTRI/2023/08/056195

Lead Sponsor: All India Institute of Medical Sciences Dr BRA IRCH New Delhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Histologically confirmed advanced (Stage 4B) or recurrent endometrioid endometrial cancer 2.Estrogen receptor (ER) positive, defined as more than or equal to 1% by IHC 3.Post menopausal women 4.ECOG PS 0-2 5.Measurable or evaluable disease with at least one target lesion which could be used for response evaluation as per RECIST 1.1 criteria. 6.The patient may have received adjuvant chemotherapy for stage 1 or 2 disease previously 7.The patient may have received any lines of chemotherapy for primary advanced disease (stage 3 or 4) or relapsed disease 8.The patient may have received external beam radiotherapy, brachytherapy or surgery 9.The patient may have received endocrine therapy before including medroxyprogesterone acetate/ megestrol or tamoxifen. 10.Adequate organ function: Hb more than or equal to 8g/dL, ANC more than or equal to 1000/uL and platelets > 100000/mm3, serum bilirubin <1.5 times institutional normal, AST/ALT <3 times ULN ( <5 if liver mets present) and ALP <3 times ULN ( <5 if liver mets present), serum creatinine <2 mg/dL; eGFR >45mL/min 11.Written informed consent

Exclusion Criteria

1.Non endometrioid adenocarcinomas, sarcomas, small cell carcinoma with Neuroendocrine differentiation or non- epithelial cancers

2.Patient with another malignancy before entering the study or a concomitant malignancy.

3.Prior use of CDK 4/6 or aromatase inhibitors

4.Uncontrolled severe comorbidities eg uncontrolled hypertension, cardiac arrythmias, unstable angina, MI Within 6 months, congestive heart failure > NYHA III, severe PAD, CTP B or C chronic liver disease, GI disorders that will impair the absorption of the study drug etc.

5.Hypersensitivity of the drugs in trial

6.Active chromic hepatitis B or C infections

7.CNS involvement

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the objective response rate (complete response plus partial response) according to RECIST v1.1 in recurrent/ metastatic endometrial cancer with palbociclib & anastrozole combinationTimepoint: at 3 months

Secondary Outcome Measures

Name	Time	Method
To assess the clinical benefit rate (complete response plus partial response plus stable disease)Timepoint: Censored at the end of study period;To assess the median Progression Free Survival (PFS) & median Overall Survival (OS)Timepoint: Censored at the end of study period;To assess the treatment related adverse events as per CTCAE v5.0.Timepoint: Throughout the study period as soon as they occur;To evaluate the change in Quality of Life (QOL) at different time points with EORTC QLQ- C30 & EN24Timepoint: At baseline, 3 months & 6 months