Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Letrozole

Immunomodulating Agents

Palbociclib

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Protein Kinase Inhibitors

Patients randomized to arm 1 will start standard Letrozole followed by Palbociclib at day 21.

Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT. Treatment may be given daily (to keep the total I-SBRT treatment time to ≤ 12 days) and lesions targeted with I-SBRT will thus be alternated each day to accommodate for the 48 hour interval between fractions.

Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT. They will undergo tumor Immunogenic-SBRT(I-SBRT) days 1-12 (+/-2 days, to enable inclusion of holidays). During the week preceding day 1, they will undergo simulation and planning for radiotherapy. Each oligometastatic lesion will be treated with I-SBRT every 48 hours. Treatment may be given daily (to keep the total I-SBRT treatment time to ≤ 12 days) and lesions targeted with I-SBRT will thus be alternated each day to accommodate for the 48 hour interval between fractions

Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions)

All patients start standard therapy with oral letrozole (Femara), day 1 of the study.

Letrozole 2.5Mg Tab

Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT.

Palbociclib 125mg

Lhaden Tshering, B.S.

Pragya Yadav, Ph.D.

Sharanya Chandrasekhar

Silvia Formenti, M.D.

Sharanya Chandrasekhar, M.S.

Hani Ashamalla, M.D.

Hina Ali, M.D.

Akkamma Ravi, M.D.

Women with Hormone Receptor (HR)+ Human Epidermal growth factor Receptor (HER)2- metastatic breast cancer are eligible to a randomized trial. Patients receiving standard first line therapy for metastatic HR+ Breast cancer(BC) (letrozole+palbociclib) are randomly assigned to also receive Stereotactic Body Radiation Therapy(SBRT) to each metastatic lesion.

Combined Immunotherapies in Metastatic ER+ Breast Cancer

CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer

Progression free survival (PFS) is defined as the time from the start of study treatment until the disease progression or death.

Serial levels ctDNA can be an early indication of progression

Circulating tumor DNA (ctDNA) levels will be measured to determine baseline cancer heterogeneity and its response to treatment

ORR is defined as the percentage of subjects with either a confirmed complete response (CR) or partial response (PR).

OS is defined as the time from the start of treatment until death.

Adverse events will be collected from patients based on CTCAE version 5.0.

Weill Medical College of Cornell University

Antirheumatic Agents

Bone Density Conservation Agents

Anti-Infective Agents

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Trastuzumab

Pertuzumab

Carboplatin

Capecitabine

Cyclophosphamide

Tamoxifen

Epirubicin

Goserelin

Ranpirnase

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

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

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)

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)

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)

cyclophosphamide

paclitaxel

trastuzumab

pertuzumab

gabor Rubovszky

Balazs Madaras

Gabor Rubovszky, Ph D

Gabor Rubovszky

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.

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.

Neoadjuvant Treatment of Breast Cancer

Neoadjuvant Treatment of Breast Cancer - a Prospective Observational Study, PANnon ONCology (PANONC) Group Non-commercial Clinical Trial

The individual participant data are not planned to be shared with other researchers but will be available upon request except personal data

study of the role of neutrophil/lymphocyte ratio (NLR) at baseline, before the 3. cycle, and before surgery. NLR is measured from the qualitative blood count as the absolute neutrophil count divided by the absolute lymphocyte count

monocyte/lymphocyte ratio (MLR) at baseline, before the 3. cycle, and before surgery. MLR is measured from the qualitative blood count as the absolute monocyte count divided by the absolute lymphocyte count

C-reactive protein serum level befor start of chemotherapy

circulating free-DNA at baseline, before 3. cycle, before surgery

from the beginning of neoadjuvant therapy to the first appearance of invasive tumor or death

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

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

to collect information all potential complaints and adverse event during and after treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combined Immunotherapies in Metastatic ER+ Breast Cancer	NCT04563507	Breast Cancer	Stereotactic Bo... Letrozole 2.5Mg... Palbociclib 125...	18 Years - 90 Years	Weill Medical College of Cornell University
Neoadjuvant Treatment of Breast Cancer	NCT05131893	Breast Cancer	Tamoxifen Goserelin Letrozole 2.5Mg... Epirubicin cyclophosphamid... Docetaxel paclitaxel trastuzumab pertuzumab Capecitabine	18 Years - 100 Years	National Institute of Oncology, Hungary

Spots Global Cancer Trial Database for letrozole 2.5mg tab