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Oral Paclitaxel + Encequidar vs IV Paclitaxel in Treatment of HER2 Negative Metastatic Breast Cancer

NCT06835400 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2025-07-11

No results posted yet for this study

Summary

The current study is being conducted to find an optimal Oral Paclitaxel + Encequidar dose and regimen based on prior experience with oral paclitaxel (stage 1) and to compare that dose to an accepted dose and regimen of intravenous (IV) paclitaxel in subjects with metastatic breast cancer (stage 2).

Conditions

Interventions

DRUG

Paclitaxel Capsule

Paclitaxel Capsule

DRUG

IV Paclitaxel

IV Paclitaxel

DRUG

Encequidar tablet

Encequidar tablet

Sponsors & Collaborators

  • Health Hope Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2028-04-30
Completion
2029-05-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06835400 on ClinicalTrials.gov