Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer

Phase 2Active Not RecruitingNCT03879577

University of Chicago53 enrolled

Overview

This is a one stage phase II study with a single arm design. It will be conducted in HER-2 positive breast cancer patients in Nigeria who are chemotherapy/hormonal treatment naive.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Breast Cancer Female HER2-positive Breast Cancer Breast Cancer Stage II Breast Cancer Stage III

Interventions

DocetaxelDRUG

Administered to all patients for a minimum of 4 cycles for 12 weeks.

HerceptinDRUG

Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel.

FECDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Women ages of 18 to 70 years old 2. Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm) 3. Patients with histologically confirmed carcinoma of the female breast with 3+ positive HER2 status by IHC 4. Clinical stages IIA -IIIC (AJCC 2009) 5. Chemotherapy-naïve patients (for this malignancy) 6. Performance status: ECOG performance status 0-1 (Appendix A) 7. Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy test and must commit to receive LHRH agonist Zoladex (goserelin) for two years starting from the commencement of the study medications 8. Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as defined by each of the following: 1\. Granulocyte ≥ 1,500/μL 2. Platelet count ≥ 100,000/μL 3. Absolute neutrophil count (ANC) ≥ l500/μL 4. Hemoglobin ≥ 10g/dL 5. Bilirubin ≤ 1.5 x upper limit of normal 6. SGOT and SGPT \< 2.5 x upper limit of normal 7. Creatinine within institutional normal limits or glomerular filtration rate ≥ 30 mL/min/1.73 m2 by CKD EPI equation (see http://mdrd.com/ for calculator) 9\. ECHO: Baseline left ventricular ejection fraction of ≥ 55% Exclusion Criteria: 1. Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients of childbearing potential will agree to continue the use of acceptable form of contraception for 24 months from the date of last Herceptin administration. 2. Patients with distant metastasis (brain and/or visceral metastasis) 3. Serious, uncontrolled, concurrent infection(s). 4. Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS) 5. Participation in any investigational drug study within 4 weeks preceding the start of study treatment 6. Other serious uncontrolled medical conditions that the investigator feels might compromise study participation including but not limited to chronic or active infection, HIV-positive patient, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled Diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements. 7. Patients with HER2-negative disease

Locations (1)

University College Hospital, Ibadan, Nigeria

Ibadan, Nigeria

Outcomes

Primary Outcomes

Number of Participants With Complete Pathologic Response (pCR)

Pathological complete response in the breast is defined as the absence of invasive cells at microscopic examination of the primary tumor and lymph nodes at surgery. Any remaining in-situ lesions are permissible. Participants with invalid/missing pCR assessments will be defined as non-responders.

Time frame: 4-6 months

Secondary Outcomes

Number of Participants With Adverse Events

Incidence and severity of adverse drug reactions (AE) and serious adverse drug reactions (SAE) including clinical laboratory values, vital signs, ECGs and dose interruptions.

Time frame: 4-6 months

Progression-free Survival (PFS)

Time from enrollment to disease recurrence or death from any cause.

Time frame: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years

Duration of Response (DOR)

Time from pathological complete response to disease recurrence or death

Time frame: Up to 10 years

Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Health From Baseline to End of Neoadjuvant Therapy.

Global health status from EORTC QLQ-C30 instrument. Overall health rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening.

Time frame: From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy

Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Quality of Life From Baseline to End of Neoadjuvant Therapy.

Data from ClinicalTrials.gov

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