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临床试验/NCT05131893
NCT05131893尚未招募不适用

Neoadjuvant Treatment of Breast Cancer - a Prospective Observational Study, PANnon ONCology (PANONC) Group Non-commercial Clinical Trial

National Institute of Oncology, Hungary1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年3月最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
pathological complete remission rate
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Observational investigation of participants who are given neoadjuvant treatment for invasive breast cancer. The scope of the study is to collect information on standardized treatment results, to explore the causes of dose modification and its effect on efficacy, to explore potential prognostic factors, and to explore the long-term side effects of different treatment modalities.

详细描述

The purpose of the study is based on the uniform application of international guidelines in Hungarian conditions. The standardized circumstances may lead to optimization of neoadjuvant therapy, it may facilitate subsequent data analysis, provide a basis for prospective clinical questions, and demonstrate improvement in pathologic complete remission (pCR) and overall survival (OS) compared to historical control. It may make possible to collect real-life data on each therapeutic option: efficacy, side effects, dose reduction, dose intensity, long-term consequences. The main scope is to collect prospective data to explore prognostic and predictive factors. The auxiliary aim is the assessment and comparison of quality of life during specific treatments and their side effects.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Participant over 18 years of age .
  • •Histologically confirmed (core biopsy) invasive breast tumor.
  • •Tumor extent for the indication:
  • •regression must be achieved for radical surgical removal or
  • •regression is required for breast-conserving surgery or
  • •if hormone receptor (HR)-positive and Her2-: stage IIB (cT2N1 or cT3NO) - IIIC,
  • •if HR-negative: stage IIA (cT2N0 or cT0-1N1) - IIIC Note: In the case of a locally advanced, irresectable case, if the possibility of radical surgery later is a realistic goal, the participant may be included in the study.
  • •Appropriate general condition: ECOG 0-1
  • •Proper organ function
  • •Neutrophil count ≥ 1.5 G / l, platelet count ≥ 100 G / l, hemoglobin ≥ 10 g / dl
  • •Alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is less than 1.5 times the upper limit of the normal range
  • •bilirubin less than 1.5 times the upper limit of the normal range (except Gilbert's disease, where less than 3 times)
  • •creatinine less than 1.5 times the upper limit of the normal range or estimated glomerular filtration rate (eGFR) higher than 60 ml / min

排除标准

  • •Proven or suspected distant metastasis.
  • •No staging studies have been performed: at least chest x-ray, abdominal ultrasound. It is preferred to perform CT from the chest, abdomen, pelvic regions and bone isotope, or PET / CT if possible in case of lymph node involvement.
  • •Known significant heart disease: major arrhythmia or significant conduction defect (grade 2 or more), infarction or unstable angina within 6 months, cardiac collapse without appropriate therapy, long QT syndrome, heart failure (≥New York Heart Association/NYHA II)
  • •Other severe acute or chronic conditions (organic or psychiatric illness, laboratory abnormality) that, in the opinion of the treating physician, result in an unacceptable increase in the risk of chemotherapy and are contraindicated in routine clinical practice.
  • •Pregnancy or if the participant does not agree to use an appropriate non-hormonal method of contraception.

研究组 & 干预措施

Her2 positive

  1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  2. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or

  3. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab

  4. Docetaxel (75 mg / m˄2) + carboplatin (AUC6) + trastuzumab +/- pertuzumab 6 times every 3 weeks c) E (90-100mg / m˄2) + C (600mg / m˄2) 4x every 2 weeks, then 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly)

干预措施: Tamoxifen (Drug)

LuminalA

  1. tamoxifen (+ LHRH analogue for premenopausal participant)
  2. non-steroidal aromatase inhibitor (+ LHRH analogue for premenopausal participant)
  3. Non-steroidal aromatase inhibitor in non-resectable tumor (+ LHRH analogue in premenopausal participant) + CDK4 / 6 inhibitor

干预措施: Tamoxifen (Drug)

LuminalA

  1. tamoxifen (+ LHRH analogue for premenopausal participant)
  2. non-steroidal aromatase inhibitor (+ LHRH analogue for premenopausal participant)
  3. Non-steroidal aromatase inhibitor in non-resectable tumor (+ LHRH analogue in premenopausal participant) + CDK4 / 6 inhibitor

干预措施: Goserelin (Drug)

LuminalA

  1. tamoxifen (+ LHRH analogue for premenopausal participant)
  2. non-steroidal aromatase inhibitor (+ LHRH analogue for premenopausal participant)
  3. Non-steroidal aromatase inhibitor in non-resectable tumor (+ LHRH analogue in premenopausal participant) + CDK4 / 6 inhibitor

干预措施: Letrozole 2.5Mg Tab (Drug)

LuminalB (Her2 negative)

  1. 12 times weekly paclitaxel (80 mg / m˄2) followed by 4 times every 3 weeks epirubicin (E) (90-100 mg / m˄2) + cyclophosphamide (C) (600) (preferred)

  2. 4x 3 weekly E (90-100mg / m˄2) + C (600mg / m˄2), then

  3. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or

  4. 12x weekly paclitaxel (80mg / m˄2)

  5. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then

  6. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or

  7. 12x weekly paclitaxel (80mg / m˄2)

  8. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)

干预措施: Tamoxifen (Drug)

LuminalB (Her2 negative)

  1. 12 times weekly paclitaxel (80 mg / m˄2) followed by 4 times every 3 weeks epirubicin (E) (90-100 mg / m˄2) + cyclophosphamide (C) (600) (preferred)

  2. 4x 3 weekly E (90-100mg / m˄2) + C (600mg / m˄2), then

  3. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or

  4. 12x weekly paclitaxel (80mg / m˄2)

  5. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then

  6. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or

  7. 12x weekly paclitaxel (80mg / m˄2)

  8. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)

干预措施: Goserelin (Drug)

LuminalB (Her2 negative)

  1. 12 times weekly paclitaxel (80 mg / m˄2) followed by 4 times every 3 weeks epirubicin (E) (90-100 mg / m˄2) + cyclophosphamide (C) (600) (preferred)

  2. 4x 3 weekly E (90-100mg / m˄2) + C (600mg / m˄2), then

  3. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or

  4. 12x weekly paclitaxel (80mg / m˄2)

  5. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then

  6. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or

  7. 12x weekly paclitaxel (80mg / m˄2)

  8. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)

干预措施: Letrozole 2.5Mg Tab (Drug)

LuminalB (Her2 negative)

  1. 12 times weekly paclitaxel (80 mg / m˄2) followed by 4 times every 3 weeks epirubicin (E) (90-100 mg / m˄2) + cyclophosphamide (C) (600) (preferred)

  2. 4x 3 weekly E (90-100mg / m˄2) + C (600mg / m˄2), then

  3. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or

  4. 12x weekly paclitaxel (80mg / m˄2)

  5. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then

  6. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or

  7. 12x weekly paclitaxel (80mg / m˄2)

  8. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)

干预措施: Epirubicin (Drug)

LuminalB (Her2 negative)

  1. 12 times weekly paclitaxel (80 mg / m˄2) followed by 4 times every 3 weeks epirubicin (E) (90-100 mg / m˄2) + cyclophosphamide (C) (600) (preferred)

  2. 4x 3 weekly E (90-100mg / m˄2) + C (600mg / m˄2), then

  3. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or

  4. 12x weekly paclitaxel (80mg / m˄2)

  5. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then

  6. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or

  7. 12x weekly paclitaxel (80mg / m˄2)

  8. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)

干预措施: cyclophosphamide (Drug)

LuminalB (Her2 negative)

  1. 12 times weekly paclitaxel (80 mg / m˄2) followed by 4 times every 3 weeks epirubicin (E) (90-100 mg / m˄2) + cyclophosphamide (C) (600) (preferred)

  2. 4x 3 weekly E (90-100mg / m˄2) + C (600mg / m˄2), then

  3. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or

  4. 12x weekly paclitaxel (80mg / m˄2)

  5. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then

  6. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or

  7. 12x weekly paclitaxel (80mg / m˄2)

  8. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)

干预措施: Docetaxel (Drug)

LuminalB (Her2 negative)

  1. 12 times weekly paclitaxel (80 mg / m˄2) followed by 4 times every 3 weeks epirubicin (E) (90-100 mg / m˄2) + cyclophosphamide (C) (600) (preferred)

  2. 4x 3 weekly E (90-100mg / m˄2) + C (600mg / m˄2), then

  3. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or

  4. 12x weekly paclitaxel (80mg / m˄2)

  5. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then

  6. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or

  7. 12x weekly paclitaxel (80mg / m˄2)

  8. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)

干预措施: paclitaxel (Drug)

LuminalB (Her2 negative)

  1. 12 times weekly paclitaxel (80 mg / m˄2) followed by 4 times every 3 weeks epirubicin (E) (90-100 mg / m˄2) + cyclophosphamide (C) (600) (preferred)

  2. 4x 3 weekly E (90-100mg / m˄2) + C (600mg / m˄2), then

  3. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or

  4. 12x weekly paclitaxel (80mg / m˄2)

  5. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then

  6. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or

  7. 12x weekly paclitaxel (80mg / m˄2)

  8. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)

干预措施: trastuzumab (Drug)

Her2 positive

  1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  2. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or

  3. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab

  4. Docetaxel (75 mg / m˄2) + carboplatin (AUC6) + trastuzumab +/- pertuzumab 6 times every 3 weeks c) E (90-100mg / m˄2) + C (600mg / m˄2) 4x every 2 weeks, then 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly)

干预措施: Goserelin (Drug)

Her2 positive

  1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  2. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or

  3. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab

  4. Docetaxel (75 mg / m˄2) + carboplatin (AUC6) + trastuzumab +/- pertuzumab 6 times every 3 weeks c) E (90-100mg / m˄2) + C (600mg / m˄2) 4x every 2 weeks, then 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly)

干预措施: Letrozole 2.5Mg Tab (Drug)

Her2 positive

  1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  2. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or

  3. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab

  4. Docetaxel (75 mg / m˄2) + carboplatin (AUC6) + trastuzumab +/- pertuzumab 6 times every 3 weeks c) E (90-100mg / m˄2) + C (600mg / m˄2) 4x every 2 weeks, then 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly)

干预措施: Epirubicin (Drug)

Her2 positive

  1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  2. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or

  3. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab

  4. Docetaxel (75 mg / m˄2) + carboplatin (AUC6) + trastuzumab +/- pertuzumab 6 times every 3 weeks c) E (90-100mg / m˄2) + C (600mg / m˄2) 4x every 2 weeks, then 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly)

干预措施: cyclophosphamide (Drug)

Her2 positive

  1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  2. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or

  3. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab

  4. Docetaxel (75 mg / m˄2) + carboplatin (AUC6) + trastuzumab +/- pertuzumab 6 times every 3 weeks c) E (90-100mg / m˄2) + C (600mg / m˄2) 4x every 2 weeks, then 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly)

干预措施: Docetaxel (Drug)

Her2 positive

  1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  2. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or

  3. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab

  4. Docetaxel (75 mg / m˄2) + carboplatin (AUC6) + trastuzumab +/- pertuzumab 6 times every 3 weeks c) E (90-100mg / m˄2) + C (600mg / m˄2) 4x every 2 weeks, then 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly)

干预措施: paclitaxel (Drug)

Her2 positive

  1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  2. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or

  3. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab

  4. Docetaxel (75 mg / m˄2) + carboplatin (AUC6) + trastuzumab +/- pertuzumab 6 times every 3 weeks c) E (90-100mg / m˄2) + C (600mg / m˄2) 4x every 2 weeks, then 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly)

干预措施: trastuzumab (Drug)

Her2 positive

  1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  2. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or

  3. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab

  4. Docetaxel (75 mg / m˄2) + carboplatin (AUC6) + trastuzumab +/- pertuzumab 6 times every 3 weeks c) E (90-100mg / m˄2) + C (600mg / m˄2) 4x every 2 weeks, then 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly)

干预措施: pertuzumab (Drug)

Triple-negative breast cancer

  1. Paclitaxel (80 mg / m˄2) +/- carboplatin (AUC2) 12 times weekly, then E (90-100 mg / m˄2) + C (600 mg / m˄2) 4 times three weekly (preferred)

  2. 4x every 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  3. 4x docetaxel (90-100mg / m˄2) or

  4. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2 )

  5. 4x every 2 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  6. 4 times every 2 weeks paclitaxel (175 mg / m˄2) or

  7. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2)

干预措施: Epirubicin (Drug)

Triple-negative breast cancer

  1. Paclitaxel (80 mg / m˄2) +/- carboplatin (AUC2) 12 times weekly, then E (90-100 mg / m˄2) + C (600 mg / m˄2) 4 times three weekly (preferred)

  2. 4x every 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  3. 4x docetaxel (90-100mg / m˄2) or

  4. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2 )

  5. 4x every 2 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  6. 4 times every 2 weeks paclitaxel (175 mg / m˄2) or

  7. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2)

干预措施: cyclophosphamide (Drug)

Triple-negative breast cancer

  1. Paclitaxel (80 mg / m˄2) +/- carboplatin (AUC2) 12 times weekly, then E (90-100 mg / m˄2) + C (600 mg / m˄2) 4 times three weekly (preferred)

  2. 4x every 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  3. 4x docetaxel (90-100mg / m˄2) or

  4. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2 )

  5. 4x every 2 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  6. 4 times every 2 weeks paclitaxel (175 mg / m˄2) or

  7. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2)

干预措施: Docetaxel (Drug)

Triple-negative breast cancer

  1. Paclitaxel (80 mg / m˄2) +/- carboplatin (AUC2) 12 times weekly, then E (90-100 mg / m˄2) + C (600 mg / m˄2) 4 times three weekly (preferred)

  2. 4x every 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  3. 4x docetaxel (90-100mg / m˄2) or

  4. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2 )

  5. 4x every 2 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  6. 4 times every 2 weeks paclitaxel (175 mg / m˄2) or

  7. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2)

干预措施: paclitaxel (Drug)

Triple-negative breast cancer

  1. Paclitaxel (80 mg / m˄2) +/- carboplatin (AUC2) 12 times weekly, then E (90-100 mg / m˄2) + C (600 mg / m˄2) 4 times three weekly (preferred)

  2. 4x every 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  3. 4x docetaxel (90-100mg / m˄2) or

  4. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2 )

  5. 4x every 2 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then

  6. 4 times every 2 weeks paclitaxel (175 mg / m˄2) or

  7. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2)

干预措施: Capecitabine (Drug)

结局指标

主要结局

pathological complete remission rate

时间窗: 3 year, maximum

no invasive tumor in breast and axilla

次要结局

  • European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)(4 years)
  • invasive disease-free survival(10 years)
  • European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ BR45)(4 years)
  • evaluation of side effects(10 years)

研究者

发起方
National Institute of Oncology, Hungary
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Zoltan Matrai

Head of Surgical Oncology

National Institute of Oncology, Hungary

研究点 (1)

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