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

The University of Chicago

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer Stage II; Breast Cancer; Breast Cancer Female; Breast Cancer Stage III; HER2-positive Breast Cancer

Treatments: Drug: Letrozole; Drug: Docetaxel; Drug: Herceptin; Drug: LHRH agonist; Drug: FEC; Drug: Tamoxifen

Study type: Interventional

Funder types: Other

Identifiers

NCT03879577

IRB18-1178

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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:

9. 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)

10. 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 5 patient groups

Docetaxel

Experimental group

Description:

Investigators will give patients docetaxel through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done.

Treatment:

Drug: Docetaxel

Herceptin

Other group

Description:

Herceptin will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive

Treatment:

Drug: Herceptin

Fluorouracil Epirubicin Hydrochloride Cyclophonsphamide (FEC)

Other group

Description:

Patients with a poor response to docetaxal will receive FEC injection by drip every 3 weeks.

Treatment:

Drug: FEC

LHRH (luteinizing hormone-releasing hormone)

Other group

Description:

All Premenopausal patients will receive LHRH agonist for two years every 3 months for contraception and fertility preservation.

Treatment:

Drug: LHRH agonist

Tamoxifen or letrozole

Other group

Description:

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 and according to the state of primary menopause at the onset of the study.

Treatment:

Drug: Letrozole

Drug: Tamoxifen