Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery

Breast Cancer Clinical Trial

Official title:

Assessing the Efficacy and Safety of Optimal Neoadjuvant to Adjuvant Anti-HER2- Based Therapy in Nigerian Women With HER2+ Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06348134
• Other study ID #: IRB23-0502
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2024
• Est. completion date: July 1, 2036

Study information

• Verified date: March 2024
• Source: University of Chicago
• Contact: Olufunmilayo Olopade
• Phone: (773) 702-1632
• Email: folopade[@]medicine.bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.

Description:

Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery. Participants with HER2-positive breast cancer will receive a combination of trastuzumab with pertuzumab (PHESGO) plus chemotherapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: July 1, 2036
• Est. primary completion date: July 1, 2034
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Written informed consent must be obtained prior to any screening procedures

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. Measurable breast tumour using ultrasonography (= 2cm)

4. Patients with histologically confirmed carcinoma of the female breast with positive HER2 status

5. Clinical stages 2A -3C. (AJCC 2009)

6. Chemotherapy-naïve patients (for this malignancy)

7. Performance status: Eastern Cooperative Oncology Group performance status 0-3

8. Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy test and must commit to receive hormone therapy with Zoladex (goserelin) for two years starting from the commencement of the study medications

9. Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as defined by each of the following:

1. Granulocyte = 1,500/mL 2. Platelet count = 100,000/mL 3. Absolute neutrophil count = l500/mL 4. Hemoglobin 10g/dL 5. Bilirubin = 1.5 x upper limit of normal 6. serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (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 Chronic Kidney Disease Epidemiology Collaboration equation (see http://mdrd.com/ for calculator) 8. Echocardiogram: Baseline left ventricular ejection fraction of = 55%

Exclusion Criteria:

Patients eligible for this study must not meet any of the following criteria:

1. Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrhoeic 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 7 months from the date of last drug administration (Herceptin).

2. Patients with distant 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

9. Patients with human epidermal growth factor receptor 2 (HER2-negative) disease

10. History of documented heart failure or systolic dysfunction (LVEF < 50%), High-risk uncontrolled arrhythmias ie, atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade Atrioventricular (AV)-block (second degree AV-block Type 2 [Mobitz 2] or third degree AV-block),

11. Angina pectoris requiring anti-anginal medication,

12. Clinically significant valvular heart disease

13. Poorly controlled hypertension (eg, systolic > 180 mm Hg or diastolic > 100 mm Hg)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer
• Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Intervention

Drug:
• Trastuzumab emtansine
A chemotherapy drug.
• Pertuzumab Injection
A prescription medicine that is approved for use in combination with trastuzumab and docetaxel in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.
• Docetaxel
A chemotherapy drug.
• Tamoxifen
A medication used to treat breast cancer.
• Letrozole
A medication used to treat breast cancer.
• Goserelin
A hormone therapy drug.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Complete Response	Pathological complete response of giving three-weekly docetaxel + subcutaneous trastuzumab and Pertuzumab with Tamoxifen/Letrozole added ) to Nigerian women with Human epidermal growth factor receptor 2 (HER2-positive) breast cancer as assessed by the absence of invasive neoplastic cells at microscopic examination of the primary tumor and lymph nodes at surgery.	10 years
Secondary	Reported Adverse Events and clinical/medical records of participants	Reported adverse events among participants receiving three-weekly docetaxel + subcutaneous trastuzumab and Pertuzumab with Tamoxifen/Letrozole added ) to Nigerian women with Human epidermal growth factor receptor 2 (HER2-positive) breast cancer as assessed by the incidence and severity of adverse events and serious adverse drug reactions including clinical laboratory values, vital signs, electrocardiogram and dose interruptions. Adverse events will be defined by the Common Terminology Criteria for Adverse Events (CTCAE Grade 4)	10 years
Secondary	Percentage of participants who are suitable for breast-conserving surgery	To determine suitability of patients for breast conserving surgery after neoadjuvant treatment with docetaxel and PHESGO as assessed by the percentage of patients with breast conservative surgery following neoadjuvant therapy.	10 years
Secondary	Event-free survival duration reported among participants	Event-free responses defined as time from first dose of study drug treatment to progression or death due to any cause, as assessed by investigators.	10 years
Secondary	Quality of life reported among study participants	Quality of life (QoL) will be assessed by various domains of QoL over time and the changes from baseline using a QoL instrument (a global/breast module) validated by the European Organization for Research and Treatment of Cancer (EORTC)	10 years
Secondary	Genetic and epigenetic factors associated with breast cancer in Nigeria	To assess the genetic and epigenetic factors associated with breast cancer in Nigeria asa assessed by correlative study of molecular markers and tumor subtypes/tumor biology with patient's characteristics, response or resistance to treatment and participants' outcome.	10 years