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

Primary Purpose

Breast Cancer, Breast Cancer Female, HER2-positive Breast Cancer

Status

Recruiting

Phase

Phase 2

Locations

Nigeria

Study Type

Interventional

Intervention

Docetaxel

Herceptin

FEC

Tamoxifen

Letrozole

LHRH agonist

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, breast cancer stage II, Breast Cancer Stage III, Docetaxel, Herceptin, neoadjuvant treatment, nigeria

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

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:

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

Sites / Locations

University College Hospital, Ibadan, NigeriaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Other

Arm Label

Docetaxel

Herceptin

Fluorouracil Epirubicin Hydrochloride Cyclophonsphamide (FEC)

LHRH (luteinizing hormone-releasing hormone)

Tamoxifen or letrozole

Arm 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.

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

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

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 until progression free survival (PFS)

Duration of response (DOR)

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).

Blood concentrations of Herceptin SC given in combination with Docetaxel

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

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

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%.

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%.

Full Information

NCT ID

NCT03879577

First Posted

February 12, 2019

Last Updated

March 3, 2023

Sponsor

University of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT03879577

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 25, 2019 (Actual)

Primary Completion Date

September 10, 2023 (Anticipated)

Study Completion Date

April 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

breast cancer, breast cancer stage II, Breast Cancer Stage III, Docetaxel, Herceptin, neoadjuvant treatment, nigeria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Docetaxel

Arm Type

Experimental

Arm Description

Arm Title

Herceptin

Arm Type

Other

Arm Description

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

Arm Title

Fluorouracil Epirubicin Hydrochloride Cyclophonsphamide (FEC)

Arm Type

Other

Arm Description

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

Arm Title

LHRH (luteinizing hormone-releasing hormone)

Arm Type

Other

Arm Description

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

Arm Title

Tamoxifen or letrozole

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Herceptin

Other Intervention Name(s)

Trastuzumab

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

FEC

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Tamoxifen

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Letrozole

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

LHRH agonist

Intervention Description

Administered to all premenopausal patients.

Primary Outcome Measure Information:

Title

Measure the complete pathologic response (pCR)

Description

Time Frame

4-6 months

Secondary Outcome Measure Information:

Title

Number of participants with adverse events

Description

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

Title

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 10 years

Title

Duration of response (DOR)

Time Frame

From first reponse to the date of first documented disease progression or death, assessed up to 10 years

Title

Analysis of changes from baseline using the quality of life (QoL) instrument: EORTC

Description

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

Title

Blood concentrations of Herceptin SC given in combination with Docetaxel

Description

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

Time Frame

21 days

Title

Drug plasma concentration of Herceptin SC given in combination with FEC

Description

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

Time Frame

21 days

Title

The cardiac toxicity associated with TscH with FEC +scH in breast cancer patients

Description

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%.

Time Frame

Through study completion an average of two years

Title

The cardiac toxicity associated with TscH without FEC +scH in breast cancer patients

Description

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%.

Time Frame

Through study completion an average of two years

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ilona Siljander, RN

Phone

1-773-702-4298

isiljander@medicine.bsd.uchicago.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olufunmilayo I Olopade, MD

Organizational Affiliation

University of Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

University College Hospital, Ibadan, Nigeria

City

Ibadan

Country

Nigeria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chibuzor Afolabi

Phone

234-803-727-2413

gafolabi08@gmail.com

First Name & Middle Initial & Last Name & Degree

Olufunmilayo I Olopade, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

32628583

Citation

Ntekim AI, Ibraheem A, Sofoluwe AA, Kotila O, Babalola C, Karrison T, Olopade CO. ARETTA: Assessing Response to Neoadjuvant Taxotere and Subcutaneous Trastuzumab in Nigerian Women With HER2-Positive Breast Cancer: A Study Protocol. JCO Glob Oncol. 2020 Jul;6:983-990. doi: 10.1200/GO.20.00043.

Results Reference

derived

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

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