Neoadjuvant Treatment of Breast Cancer

National Institute of Oncology, Hungary

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Drug: Epirubicin; Drug: Tamoxifen; Drug: Docetaxel; Drug: cyclophosphamide; Drug: Capecitabine; Drug: pertuzumab; Drug: paclitaxel; Drug: Goserelin; Drug: Letrozole 2.5Mg Tab; Drug: trastuzumab

Study type: Observational

Funder types: Other

Identifiers

NCT05131893

PANONC-1 Version: 1.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participant over 18 years of age .

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

1. Proven or suspected distant metastasis.
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.

Trial design

300 participants in 4 patient groups

LuminalA

Description:

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

Treatment:

Drug: Letrozole 2.5Mg Tab

Drug: Tamoxifen

Drug: Goserelin

LuminalB (Her2 negative)

Description:

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)

Treatment:

Drug: Letrozole 2.5Mg Tab

Drug: paclitaxel

Drug: Epirubicin

Drug: trastuzumab

Drug: Tamoxifen

Drug: Docetaxel

Drug: cyclophosphamide

Drug: Goserelin

Her2 positive

Description:

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)

Treatment:

Drug: Letrozole 2.5Mg Tab

Drug: paclitaxel

Drug: Epirubicin

Drug: trastuzumab

Drug: Tamoxifen

Drug: Docetaxel

Drug: pertuzumab

Drug: cyclophosphamide

Drug: Goserelin

Triple-negative breast cancer

Description:

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)

Treatment:

Drug: Capecitabine

Drug: paclitaxel

Drug: Epirubicin

Drug: Docetaxel

Drug: cyclophosphamide