Health Condition 1: C541- Malignant neoplasm of endometrium
Conditions
Interventions
Intervention1: Palbociclib and anastrozole: Per cycle:
Tab Palbociclib 125mg per oral once a day for 21 days (D1-D21)
Tab Anastrozole 1mg per oral once a day for 28 days (D1-D28)
Control Interventi
Sponsors
All India Institute of Medical Sciences Dr BRA IRCH New Delhi
Eligibility
Inclusion criteria
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 45mL/min 11. Written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactChitrakshi
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed