NCT03058939

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

Assessing the REsponse Rate of Weekly Neo-adjuvanT pacliTAxel (Taxol) in Nigerian Women With Breast Cancer (ARETTA)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Each patient will be assigned one of the following groups: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 8) unknown (not assessable, insufficient data). Patients with a good response to 8 doses of paclitaxel (complete response or partial response that are operable) will receive an additional 8 courses of paclitaxel chemotherapy before surgery and radiotherapy. The overall response for these patients will be assessed by ultrasonography after a total of 16 weeks of Taxol therapy. Patients with poor response (defined as stable disease or progressive disease or partial response inoperable) as best response after eight weekly courses of paclitaxel will receive 8 cycles of weekly PC. The overall response for these patients will also be assessed by ultrasonography after 8 courses of PC therapy. Patients with poor response to 8 courses of paclitaxel followed by 8 courses of PC based on ultrasound assessment will be regarded as failing to respond to treatment. These patients will receive 4 cycles of 3-weekly FEC and will be followed up. Patients in response groups 4-8 above will be considered as failing to respond to treatment. All conclusions will be based on all eligible patients. The schema for the study is presented in Figures 4-1, 4-2 and 4-3. Patients with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time will be classified as having "symptomatic deterioration". Every effort will be made to document the objective progression even after discontinuation of treatment. All Premenopausal patients will receive LHRH agonist for two years for contraception and fertility preservation. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors ER and PgR (see glossary and section 10.3) and according to the state of primary menopause (see glossary) at the onset of the study. Patients with HER2-positive disease (see glossary and section 10.3) will receive 5 threeweekly courses of trastuzumab (Herceptin SC) with pertuzumab (Perjeta). After that pts will continue receiving trastuzumab to complete total of 18 doses within 1 year of treatment. The study is designed to estimate the RR of breast cancer patients to weekly paclitaxel chemotherapy and to determine the RR to weekly PC combination chemotherapy in patients resistant to or with poor response (including early progression) while on weekly single agent paclitaxel.

Conditions

• Breast Cancer
• Breast Cancer Stage II
• Breast Cancer Stage III

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-04-01
• Completion: 2019-06-01
• First posted: 2017-02-23
• Last updated: 2019-04-22

Locations

1 site across 1 country: Nigeria

Regulatory

• FDA-regulated drug study