A Study to evaluate Safety and Efficacy of Endoxifen in Women with Metastatic Estrogen Receptor Positive Breast Cancer

A Phase II,Multicenter, Randomized,open Label,& Parallel Group Study to Evaluate Safety and Efficacy of endoxifen as First-Line Therapy in Women with Metastatic ER positive Breast Cancer - NA

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/01/005450

Enrollment

Registered

2015-01-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Endoxifen_Intas: Dose:4 mg & 8 mg, Frequency: Once daily, Mode of Administration: Oral, Duration of treatment: 28 day cycle for 6 cycles Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: 1. The patient willing to give written signed and dated informed consent to participate in the study. 2. Premenopausal/Postmenopausal women with histologically /cytologically confirmed carcinoma of the breast who are eligible for hormonal therapy. 3. Female >=18 years of age. 4. Eastern Cooperative Oncology Group (ECOG) performance status 5. Patients with life expectancy of more than 6 months. 6. ER status of the patient should be positive in the tumor re-assessment biopsy done at the time of screening ((ER + is defined as per ASCO CAP guidelines with IHC of > 1%). 7. If prior hormonal therapy used, must be >1 year since completion of hormonal therapy. 8. Patients should have at least one measurable lesion as defined by RECIST 1.1. 9. Patients with inoperable locally advanced or metastatic breast cancer. 10. The serum pregnancy test at screening and urine pregnancy test before dosing Day 1 must be negative. 11. Patient must have an adequate bone marrow, renal and hepatic function

Exclusion criteria

Exclusion criteria: 1. Patient who have received prior endoxifen or any other hormonal or biological therapy for metastatic breast cancer. 2. Rapidly progressing or high burden visceral disease. 3. Known history of drug addiction within last 1 year of signing of ICF. 4. Patients with CNS lesions 5. The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days prior to the first dosing of investigational medicinal Product for the current study. 6. Known case of HIV infection. 7. Patient having history of coagulopathy, Deep vein thrombosis (DVT) or pulmonary embolism (PE) prior to signing ICF 8. Abnormal uterine bleeding 9. Prior diagnosis of endometrial carcinoma 10. Significant pre-existing active inflammatory bowel disease, diarrhea 11. Clinically symptomatic cataracts requiring imminent surgery. 12. Patient having history of crystalline retinopathy

Design outcomes

Primary

Measure	Time frame
To compare the Best Overall Response Rate (CR or PR) for evaluation of the efficacy of endoxifen in patients with estrogen receptor-positive breast cancer.Timepoint: 6 cycles	—

Secondary

Measure	Time frame
1.To evaluate safety of the patients who are exposed to the endoxifen 2.To compare the clinical benefit (CR or PR or SD â?¥ for at least 24 weeks (i.e. at least 168 days since start of treatment) 3.To explore the exposure-response relationship for endoxifenTimepoint: 6 cycle	—

Countries

India

Contacts

Public ContactDr Ankit Ranpura

Lambda Therapeutic Research Ltd

falgunvyas@lambda-cro.com07940202354

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026