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Assessing the Response Rate of Neo-adjuvant Paclitaxel (Taxol) in Nigerian Women With Breast Cancer

NCT03058939 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-04-22

No results posted yet for this study

Summary

This is a two-stage phase II study with a single arm design. It will be conducted in women with breast cancer with stages IIA to IIIC (defined by AJCC 2009 classification) of all histological subtypes. All patients will receive 16 doses of paclitaxel; three breast ultrasound tests and tumor pathologic response evaluation will be used to assess the response to treatment.

Conditions

Interventions

DRUG

Paclitaxel

Administered to all patients for a minimum of 8 doses with a possible maximum of 16 doses.

DRUG

Perjeta

Only administered to patients with HER2-positive disease.

DRUG

Herceptin SC

Only administered to patients with HER2-positive disease.

DRUG

Tamoxifen

Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.

DRUG

Letrozole

Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.

DRUG

LHRH agonist

Administered to all premenopausal patients.

DRUG

FEC

Only administered to patients who received paclitaxel and carboplatin, and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable).

DRUG

Carboplatin

Only administered to patients who receive paclitaxel and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable).

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Olufunmilayo I. Olopade, MD · University of Chicago Center for Global Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2019-04-30
Completion
2019-06-30
FDA Drug
Yes

Countries

  • Nigeria

Study Locations

More Related Trials

Entities

Drugs
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 NCT03058939 on ClinicalTrials.gov