Assessing REsponse to Neoadjuvant Taxotere and Trastuzumab in Nigerian Women With HER2-positive Breast Cancer (ARETTA)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Measure the complete pathologic response (pCR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Platelet count ≥ 100,000/μL
- •Absolute neutrophil count (ANC) ≥ l500/μL
- •Hemoglobin ≥ 10g/dL
- •Bilirubin ≤ 1.5 x upper limit of normal
- •SGOT and SGPT < 2.5 x upper limit of normal
- •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%
排除标准
- •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
研究组 & 干预措施
Docetaxel
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.
干预措施: Docetaxel (Drug)
Herceptin
Herceptin will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive
干预措施: Herceptin (Drug)
Fluorouracil Epirubicin Hydrochloride Cyclophonsphamide (FEC)
Patients with a poor response to docetaxal will receive FEC injection by drip every 3 weeks.
干预措施: FEC (Drug)
LHRH (luteinizing hormone-releasing hormone)
All Premenopausal patients will receive LHRH agonist for two years every 3 months for contraception and fertility preservation.
干预措施: LHRH agonist (Drug)
Tamoxifen or letrozole
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.
干预措施: Tamoxifen (Drug)
Tamoxifen or letrozole
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.
干预措施: Letrozole (Drug)
结局指标
主要结局
Measure the complete pathologic response (pCR)
时间窗: 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.
次要结局
- The cardiac toxicity associated with TscH with FEC +scH in breast cancer patients(Through study completion an average of two years)
- Number of participants with adverse events(4-6 months)
- Duration of response (DOR)(From first reponse to the date of first documented disease progression or death, assessed up to 10 years)
- Blood concentrations of Herceptin SC given in combination with Docetaxel(21 days)
- Drug plasma concentration of Herceptin SC given in combination with FEC(21 days)
- The cardiac toxicity associated with TscH without FEC +scH in breast cancer patients(Through study completion an average of two years)
- Time until progression free survival (PFS)(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)
- Analysis of changes from baseline using the quality of life (QoL) instrument: EORTC(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)