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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03058939
• Date of registration: 02/02/2017
• Prospective Registration: Yes
• Primary sponsor: University of Chicago
• Public title: Assessing the Response Rate of Neo-adjuvant Paclitaxel (Taxol) in Nigerian Women With Breast Cancer
• Scientific title: Assessing the REsponse Rate of Weekly Neo-adjuvanT pacliTAxel (Taxol) in Nigerian Women With Breast Cancer (ARETTA)
• Date of first enrolment: November 2018
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03058939
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Nigeria

Contacts

• Name: Olufunmilayo I. Olopade, MD
• Affiliation: University of Chicago Center for Global Health

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Women ages of 18 to 70 years old.

2. Biopsy-accessible breast tumor of significant size for core needle biopsy (= 2cm).

3. Patients with histologically confirmed carcinoma of the female breast with any or
unknown HRs/HER2 status

4. Clinical stages IIA -IIIC. (AJCC 2009) (Appendix A)

5. Chemotherapy-naïve patients (for this malignancy)

6. Performance status: ECOG performance status 0-3 (Appendix B)

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. Hemoglobin³10g/dL

5. Bilirubin = 1.5 x upper limit of normal

6. SGOT and SGPT < 2.5 x upper limit of normal for patients without liver metastases

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)

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 will agree to continue the use of acceptable form of contraception for 30
days from the date of last drug administration.

2. Patients with brain metastasis.

3. Serious, uncontrolled, concurrent infection(s).

4. Patients who have received more than 4 weeks of tamoxifen therapy for this malignancy.
Patient who have received tamoxifen or raloxifene for purposes of chemoprevention
(e.g. Breast Cancer Prevention Trial or for other past indications (including previous
breast cancer) are eligible. Tamoxifen or raloxifene therapy will be discontinued at
least one month before the patient is enrolled on this study.

5. Treatment for other carcinomas within the last 5 years, except non-melanoma skin
cancer and treated cervical carcinoma in-situ (CCIS).

6. Participation in any investigational drug study within 4 weeks preceding the start of
study treatment.

7. 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.

8. Unwillingness to participate or inability to comply with the protocol for the duration
of the study.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Breast Cancer Stage III

Breast Cancer Stage II

Intervention(s)

Drug: Herceptin SC

Drug: Carboplatin

Drug: Tamoxifen

Drug: FEC

Drug: Letrozole

Drug: LHRH agonist

Drug: Paclitaxel

Drug: Perjeta

Primary Outcome(s)

Measure overall clinical response rate (OCR) [Time Frame: 24 months]

Measure of complete pathologic response (pCR) [Time Frame: 24 months]

Secondary Outcome(s)

Number of participants with adverse events [Time Frame: 24 months]

Analysis of hormone recepters (ER and PgR) and HER2 [Time Frame: Through study completion an average of two years]

Blood concentrations of Herceptin SC before each dose of Herceptin/paclitaxel/PC [Time Frame: 24 months]

Blood concentrations of Perjeta before each dose of Perjeta/Herceptin/paclitaxel/PC [Time Frame: 24 months]

Duration of response (DOR) [Time Frame: From first reponse to the date of first documented disease progression, assessed up to 24 months]

Analysis of changes from baseline using the quality of life (QoL) instrument [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 100 months.]

Time until progression free survival (PFS) [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 100 months]

To assess the genetic and epigenetic factors associated with breast cancer in Nigeria [Time Frame: From start date of therapy to the date of death from any cause, assessed up to 100 months]

Secondary ID(s)

IRB15-1005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors