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NCT Number: NCT03879577

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Cancer Female Breast Cancer Stage II Breast Cancer Stage III Breast Diseases Breast Neoplasms HER2-positive Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University College Hospital, Ibadan, Nigeria

Ibadan, Nigeria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women ages of 18 to 70 years old
  • Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
  • Patients with histologically confirmed carcinoma of the female breast with 3+ positive HER2 status by IHC
  • Clinical stages IIA -IIIC (AJCC 2009)
  • Chemotherapy-naïve patients (for this malignancy)
  • Performance status: ECOG performance status 0-1 (Appendix A)
  • 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
  • Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as defined by each of the following:
  • 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)
  • ECHO: Baseline left ventricular ejection fraction of ≥ 55%

Exclusion criteria

  • 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.
  • Patients with distant metastasis (brain and/or visceral metastasis)
  • Serious, uncontrolled, concurrent infection(s).
  • Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
  • Participation in any investigational drug study within 4 weeks preceding the start of study treatment
  • 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.
  • Patients with HER2-negative disease

Treatment and study plan

docetaxel

Drug

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

Herceptin

Drug

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

Other names: Trastuzumab

FEC

Drug

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

Drug

Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.

letrozole

Drug

Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.

LHRH Agonist

Drug

Administered to all premenopausal patients.

Primary outcomes

  1. Number of Participants With Complete Pathologic Response (pCR)

    Time frame: 4-6 months

    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.

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 4-6 months

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

  2. 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 10 years

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

  3. Duration of Response (DOR)

    Time frame: Up to 10 years

    Time from pathological complete response to disease recurrence or death

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

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

    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.

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

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

    Global quality of life status from EORTC QLQ-C30 instrument. Overall quality of life 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.

  6. Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Health From Baseline to 6 Months Post-therapy.

    Time frame: From start date of therapy to 6 months post-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.

  7. Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Quality of Life From Baseline to 6 Months Post-therapy.

    Time frame: From start date of therapy to 6 months post-therapy

    Global quality of life status from EORTC QLQ-C30 instrument. Overall quality of life 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.

  8. Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC

    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

    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).

  9. Blood Concentrations of Herceptin SC Given in Combination With Docetaxel

    Time frame: 21 days

    Blood concentrations of Herceptin SC at multiple time points using the peak exposure

  10. Drug Plasma Concentration of Herceptin SC Given in Combination With FEC

    Time frame: 21 days

    Determine the pharmacokinetic profile of Herceptin SC given in combination with FEC following poor response to TH

  11. The Cardiac Toxicity Associated With TscH With FEC +scH in Breast Cancer Patients

    Time frame: Through study completion an average of two years

    The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) or a decrease in LVEF of at least 10 EF points from baseline and to below 50%.

  12. The Cardiac Toxicity Associated With TscH Without FEC +scH in Breast Cancer Patients

    Time frame: Through study completion an average of two years

    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%.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2026
First posted
Mar 19, 2019
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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