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

Breast Cancer Clinical Trial

Official title:

Assessing REsponse to Neoadjuvant Taxotere and Trastuzumab in Nigerian Women With HER2-positive Breast Cancer (ARETTA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03879577
• Other study ID #: IRB18-1178
• Status: Recruiting
• Phase: Phase 2
• Start date: November 25, 2019
• Est. completion date: April 10, 2024

Study information

• Verified date: March 2023
• Source: University of Chicago
• Contact: Ilona Siljander, RN
• Phone: 1-773-702-4298
• Email: isiljander[@]medicine.bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 10, 2024
• Est. primary completion date: September 10, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Docetaxel
Administered to all patients for a minimum of 4 cycles for 12 weeks.
• Herceptin
Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel.
• FEC
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).
• Tamoxifen
Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.
• Letrozole
Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.
• LHRH agonist
Administered to all premenopausal patients.

Locations

Country	Name	City	State
Nigeria	University College Hospital, Ibadan, Nigeria	Ibadan

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the 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.	4-6 months
Secondary	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.	4-6 months
Secondary	Time until progression free survival (PFS)		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
Secondary	Duration of response (DOR)		From first reponse to the date of first documented disease progression or death, assessed up to 10 years
Secondary	Analysis of changes from baseline using the quality of life (QoL) instrument: EORTC	The various domains of QoL over time and the changes from baseline using the validated (by the European Organization for Research and Treatment of Cancer (EORTC)) QoL instrument (global and breast module).	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
Secondary	Blood concentrations of Herceptin SC given in combination with Docetaxel	Blood concentrations of Herceptin SC at multiple time points using the peak exposure	21 days
Secondary	Drug plasma concentration of Herceptin SC given in combination with FEC	Determine the pharmacokinetic profile of Herceptin SC given in combination with FEC following poor response to TH	21 days
Secondary	The cardiac toxicity associated with TscH with FEC +scH in breast cancer patients	The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) and a decrease in LVEF of at least 10 EF points from baseline and to below 50%.	Through study completion an average of two years
Secondary	The cardiac toxicity associated with TscH without FEC +scH in breast cancer patients	The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) and a decrease in LVEF of at least 10 EF points from baseline and to below 50%.	Through study completion an average of two years