Breast CancerNCT05131893
Neoadjuvant Treatment of Breast Cancer
An observational study of Breast Cancer, run by National Institute of Oncology, Hungary at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tamoxifen, Goserelin and Letrozole 2.5Mg Tab
- How many people
- 300 participants
- Where
- 1 siteHungary
- Study dates
- Mar 2022to Dec 2031
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients for whom neoadjuvant therapy is proposed by multidisciplinary team
Who may be able to join
- 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,
Show all 13Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site
National Institute of Oncolgy
Budapest, 1122
Gabor Rubovszky, Ph D, +3612248600 ext. 3442, garub@oncol.hu
Balazs Madaras, +3612248600, madarasb@gmail.com
About this study
Official title: Neoadjuvant Treatment of Breast Cancer - a Prospective Observational Study, PANnon ONCology (PANONC) Group Non-commercial Clinical Trial
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Tamoxifen, Goserelin, Letrozole 2.5Mg Tab, Epirubicin, cyclophosphamide
- Keywords
- Neoadjuvant systemic therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
endocrine therapy
GoserelinDrug
endocrine therapy
Letrozole 2.5Mg TabDrug
Also called letrozole
endocrine therapy
EpirubicinDrug
chemotherapy
cyclophosphamideDrug
chemotherapy
DocetaxelDrug
chemotherapy
paclitaxelDrug
chemotherapy
trastuzumabDrug
biological treatment
pertuzumabDrug
biological treatment
CapecitabineDrug
chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: 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) Receives: 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) Receives: Drug: Epirubicin; Drug: cyclophosphamide; Drug: Docetaxel; Drug: paclitaxel; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete remission rate
no invasive tumor in breast and axilla
Measured: 3 year, maximum
Secondary outcomes (4)
invasive disease-free survival
from the beginning of neoadjuvant therapy to the first appearance of invasive tumor or death
Measured: 10 years
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Global health status, functional and symptom scales survey using the EORTC QLQ-C30 questionnaire before cycle 1, before cycle 4, after the last neoadjuvant chemotherapy, and before surgery, 1 year after chemotherapy
Measured: 4 years
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ BR45)
Breast cancer-specific functional scales and symptom scales survey using the EORTC QLQ BR45 questionnaire before cycle 1, before cycle 4, after the last neoadjuvant chemotherapy, and before surgery, 1 year after chemotherapy
Measured: 4 years
evaluation of side effects
to collect information all potential complaints and adverse event during and after treatment
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study startMar 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- National Institute of Oncology, Hungary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Zoltan Matrai, National Institute of Oncology, Hungary
- Investigators
- Gabor Rubovszky, Principal investigator, NIO Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131893
- Sponsor's protocol ID
- PANONC-1 Version: 1.1
- Status last verified
- Nov 2021
- First submitted
- 30 Jul 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data are not planned to be shared with other researchers but will be available upon request except personal data
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment of Breast Cancer - a Prospective Observational Study, PANnon ONCology (PANONC) Group Non-commercial Clinical Trial
- ClinicalTrials.gov ID
- NCT05131893
- Acronym / sponsor ID
- PANONC-1 Version: 1.1
- Conditions
- Breast Cancer
- Keywords
- Neoadjuvant systemic therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Institute of Oncology, HungaryUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LuminalA | – | Drug: Tamoxifen, Drug: Goserelin, Drug: Letrozole 2.5Mg Tab1. 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 |
| LuminalB (Her2 negative) | – | Drug: Tamoxifen, Drug: Goserelin, Drug: Letrozole 2.5Mg Tab, Drug: Epirubicin, Drug: cyclophosphamide, Drug: Docetaxel, Drug: paclitaxel, Drug: trastuzumab1. 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) |
| Her2 positive | – | Drug: Tamoxifen, Drug: Goserelin, Drug: Letrozole 2.5Mg Tab, Drug: Epirubicin, Drug: cyclophosphamide, Drug: Docetaxel, Drug: paclitaxel, Drug: trastuzumab, Drug: pertuzumab1. 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) |
| Triple-negative breast cancer | – | Drug: Epirubicin, Drug: cyclophosphamide, Drug: Docetaxel, Drug: paclitaxel, Drug: Capecitabine1. 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) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients for whom neoadjuvant therapy is proposed by multidisciplinary team
Key inclusion criteria (13 listed)
- Participant over 18 years of age .
- Histologically confirmed (core biopsy) invasive breast tumor.
- Tumor extent for the indication:
- Appropriate general condition: ECOG 0-1
- Proper organ function
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamoxifenendocrine therapy | Drug | Her2 positive, LuminalA, LuminalB (Her2 negative) |
| Goserelinendocrine therapy | Drug | Her2 positive, LuminalA, LuminalB (Her2 negative) |
| Letrozole 2.5Mg TabAlso: letrozoleendocrine therapy | Drug | Her2 positive, LuminalA, LuminalB (Her2 negative) |
| Epirubicinchemotherapy | Drug | Her2 positive, LuminalB (Her2 negative), Triple-negative breast cancer |
| cyclophosphamidechemotherapy | Drug | Her2 positive, LuminalB (Her2 negative), Triple-negative breast cancer |
| Docetaxelchemotherapy | Drug | Her2 positive, LuminalB (Her2 negative), Triple-negative breast cancer |
| paclitaxelchemotherapy | Drug | Her2 positive, LuminalB (Her2 negative), Triple-negative breast cancer |
| trastuzumabbiological treatment | Drug | Her2 positive, LuminalB (Her2 negative) |
| pertuzumabbiological treatment | Drug | Her2 positive |
| Capecitabinechemotherapy | Drug | Triple-negative breast cancer |
Primary outcome
pathological complete remission rate
Time frame: 3 year, maximum
no invasive tumor in breast and axilla
4 secondary outcomes
invasive disease-free survival
Time frame: 10 years
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: 4 years
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ BR45)
Time frame: 4 years
evaluation of side effects
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Individual participant dataSharing planned: No. The individual participant data are not planned to be shared with other researchers but will be available upon request except personal data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabor Rubovszky principal investigator
NIO Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by National Institute of Oncology, Hungary at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact gabor Rubovszky (+3612248600 ext. 3442, garub@oncol.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete remission rate (time frame: 3 year, maximum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.