CLINICAL TRIAL / NCT06348134
Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery
- Interventional
- Recruiting
- NCT06348134
Contact Information
Assessing the Efficacy and Safety of Optimal Neoadjuvant to Adjuvant Anti-HER2- Based Therapy in Nigerian Women With HER2+ Breast Cancer
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.
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.
Gender
Female
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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)