Neoadjuvant Treatment of Breast Cancer

NCT05131893 | Not Yet Recruiting FDA Drug

• 1 other identifier: PANONC-1 Version: 1.1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Neoadjuvant systemic therapy

Outcome Measures

Primary Outcomes (1)

• pathological complete remission rate

  no invasive tumor in breast and axilla

  3 year, maximum

Secondary Outcomes (4)

• invasive disease-free survival

  10 years

• European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  4 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

Other Outcomes (5)

• dose density assessment

  3 year, maximum

• investigate the potential prognostic effect of neutrophil/lymphocyte ratio

  10 years

• investigate the potential prognostic effect of monocyte/lymphocyte ratio

  10 years

Study Arms (4)

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

Drug: Tamoxifen; Drug: Goserelin; Drug: 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)

Drug: Tamoxifen; Drug: Goserelin; Drug: Letrozole 2.5Mg Tab; Drug: Epirubicin; Drug: cyclophosphamide; Drug: Docetaxel; Drug: paclitaxel; Drug: 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)

Drug: Tamoxifen; Drug: Goserelin; Drug: Letrozole 2.5Mg Tab; Drug: Epirubicin; Drug: cyclophosphamide; Drug: Docetaxel; Drug: paclitaxel; Drug: trastuzumab; Drug: 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)

Drug: Epirubicin; Drug: cyclophosphamide; Drug: Docetaxel; Drug: paclitaxel; Drug: Capecitabine

Interventions

Tamoxifen DRUG

endocrine therapy

Her2 positive; LuminalA; LuminalB (Her2 negative)

Goserelin DRUG

endocrine therapy

Her2 positive; LuminalA; LuminalB (Her2 negative)

Letrozole 2.5Mg Tab DRUG

endocrine therapy

Also known as: letrozole

Her2 positive; LuminalA; LuminalB (Her2 negative)

Epirubicin DRUG

chemotherapy

Her2 positive; LuminalB (Her2 negative); Triple-negative breast cancer

cyclophosphamide DRUG

chemotherapy

Her2 positive; LuminalB (Her2 negative); Triple-negative breast cancer

Docetaxel DRUG

chemotherapy

Her2 positive; LuminalB (Her2 negative); Triple-negative breast cancer

paclitaxel DRUG

chemotherapy

Her2 positive; LuminalB (Her2 negative); Triple-negative breast cancer

trastuzumab DRUG

biological treatment

Her2 positive; LuminalB (Her2 negative)

pertuzumab DRUG

biological treatment

Her2 positive

Capecitabine DRUG

chemotherapy

Triple-negative breast cancer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients for whom neoadjuvant therapy is proposed by multidisciplinary team

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Oncology, Hungary: lead

Study Sites (1)

National Institute of Oncolgy

Budapest, 1122, Hungary

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen; Goserelin; Letrozole; Epirubicin; Cyclophosphamide; Docetaxel; Paclitaxel; Trastuzumab; pertuzumab; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Gabor Rubovszky

  NIO Hungary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

gabor Rubovszky

CONTACT

+3612248600; garub@oncol.hu

Balazs Madaras

CONTACT

+3612248600; madarasb@oncol.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Surgical Oncology

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: November 23, 2021
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion (Estimated): December 1, 2031
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)