Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
300 participants
OBSERVATIONAL
2022-03-31
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Tamoxifen
endocrine therapy
Goserelin
endocrine therapy
Letrozole 2.5Mg Tab
endocrine therapy
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)
Tamoxifen
endocrine therapy
Goserelin
endocrine therapy
Letrozole 2.5Mg Tab
endocrine therapy
Epirubicin
chemotherapy
cyclophosphamide
chemotherapy
Docetaxel
chemotherapy
paclitaxel
chemotherapy
trastuzumab
biological treatment
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)
Tamoxifen
endocrine therapy
Goserelin
endocrine therapy
Letrozole 2.5Mg Tab
endocrine therapy
Epirubicin
chemotherapy
cyclophosphamide
chemotherapy
Docetaxel
chemotherapy
paclitaxel
chemotherapy
trastuzumab
biological treatment
pertuzumab
biological treatment
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)
Epirubicin
chemotherapy
cyclophosphamide
chemotherapy
Docetaxel
chemotherapy
paclitaxel
chemotherapy
Capecitabine
chemotherapy
Interventions
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Tamoxifen
endocrine therapy
Goserelin
endocrine therapy
Letrozole 2.5Mg Tab
endocrine therapy
Epirubicin
chemotherapy
cyclophosphamide
chemotherapy
Docetaxel
chemotherapy
paclitaxel
chemotherapy
trastuzumab
biological treatment
pertuzumab
biological treatment
Capecitabine
chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed (core biopsy) invasive breast tumor.
3. 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.
4. Appropriate general condition: ECOG 0-1
5. 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
Exclusion Criteria
2. 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.
3. 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)
4. 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.
5. Pregnancy or if the participant does not agree to use an appropriate non-hormonal method of contraception.
18 Years
100 Years
ALL
No
Sponsors
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National Institute of Oncology, Hungary
OTHER
Responsible Party
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Dr. Zoltan Matrai
Head of Surgical Oncology
Principal Investigators
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Gabor Rubovszky
Role: PRINCIPAL_INVESTIGATOR
NIO Hungary
Locations
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National Institute of Oncolgy
Budapest, , Hungary
Countries
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Central Contacts
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Facility Contacts
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Gabor Rubovszky, Ph D
Role: primary
Balazs Madaras
Role: backup
Other Identifiers
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PANONC-1 Version: 1.1
Identifier Type: -
Identifier Source: org_study_id