Neoadjuvant Treatment of Breast Cancer - a Prospective Observational Study, PANnon ONCology (PANONC) Group Non-commercial Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Tamoxifen
- Conditions
- Breast Cancer
- Sponsor
- National Institute of Oncology, Hungary
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- pathological complete remission rate
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Dr. Zoltan Matrai
Head of Surgical Oncology
National Institute of Oncology, Hungary
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Her2 positive
1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then 1. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or 2. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab 2. 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)
Intervention: Tamoxifen
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
Intervention: Tamoxifen
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
Intervention: Goserelin
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
Intervention: Letrozole 2.5Mg Tab
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 1. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or 2. 12x weekly paclitaxel (80mg / m˄2) 3. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then 1. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) 4. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)
Intervention: Tamoxifen
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 1. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or 2. 12x weekly paclitaxel (80mg / m˄2) 3. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then 1. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) 4. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)
Intervention: Goserelin
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 1. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or 2. 12x weekly paclitaxel (80mg / m˄2) 3. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then 1. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) 4. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)
Intervention: Letrozole 2.5Mg Tab
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 1. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or 2. 12x weekly paclitaxel (80mg / m˄2) 3. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then 1. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) 4. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)
Intervention: Epirubicin
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 1. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or 2. 12x weekly paclitaxel (80mg / m˄2) 3. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then 1. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) 4. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)
Intervention: cyclophosphamide
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 1. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or 2. 12x weekly paclitaxel (80mg / m˄2) 3. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then 1. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) 4. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)
Intervention: Docetaxel
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 1. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or 2. 12x weekly paclitaxel (80mg / m˄2) 3. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then 1. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) 4. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)
Intervention: paclitaxel
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 1. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or 2. 12x weekly paclitaxel (80mg / m˄2) 3. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then 1. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) 4. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)
Intervention: trastuzumab
Her2 positive
1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then 1. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or 2. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab 2. 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)
Intervention: Goserelin
Her2 positive
1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then 1. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or 2. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab 2. 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)
Intervention: Letrozole 2.5Mg Tab
Her2 positive
1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then 1. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or 2. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab 2. 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)
Intervention: Epirubicin
Her2 positive
1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then 1. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or 2. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab 2. 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)
Intervention: cyclophosphamide
Her2 positive
1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then 1. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or 2. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab 2. 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)
Intervention: Docetaxel
Her2 positive
1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then 1. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or 2. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab 2. 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)
Intervention: paclitaxel
Her2 positive
1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then 1. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or 2. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab 2. 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)
Intervention: trastuzumab
Her2 positive
1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then 1. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or 2. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab 2. 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)
Intervention: pertuzumab
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 1. 4x docetaxel (90-100mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2 ) 3. 4x every 2 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then 1. 4 times every 2 weeks paclitaxel (175 mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2)
Intervention: Epirubicin
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 1. 4x docetaxel (90-100mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2 ) 3. 4x every 2 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then 1. 4 times every 2 weeks paclitaxel (175 mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2)
Intervention: cyclophosphamide
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 1. 4x docetaxel (90-100mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2 ) 3. 4x every 2 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then 1. 4 times every 2 weeks paclitaxel (175 mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2)
Intervention: Docetaxel
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 1. 4x docetaxel (90-100mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2 ) 3. 4x every 2 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then 1. 4 times every 2 weeks paclitaxel (175 mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2)
Intervention: paclitaxel
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 1. 4x docetaxel (90-100mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2 ) 3. 4x every 2 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then 1. 4 times every 2 weeks paclitaxel (175 mg / m˄2) or 2. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2)
Intervention: Capecitabine
Outcomes
Primary Outcomes
pathological complete remission rate
Time Frame: 3 year, maximum
no invasive tumor in breast and axilla
Secondary Outcomes
- 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)