Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle

6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.

Cabazitaxel

Amit K Bahl

Alicia Bravo

Shola Ogegbo

Tania Allen

Lauren Thornborough

Alison Markham

Clare Boobier

Kizzy Baines

Chris Bayliss

Lucy Blackwell

Carol Tasker

helen smith

Angela Locke

Carol Goddard

Jayne tyler

90 patients with HER2 negative breast cancer will be randomised to receive 18 weeks of chemotherapy treatment, either 6 cycles of 3 weekly Cabazitaxel or 6 cycles of weekly Paclitaxel to determine the difference in progression free survival between the 2 groups. If results at that stage suggest a potential benefit then the trial will be developed further to accrue 70 more patients.

This is a prospective multicentre, randomised, open label, study comparing the efficacy and the safety of six 3-weekly cycles cabazitaxel versus 18 x weekly paclitaxel given as first line chemotherapy treatment in patients with HER2-normal metastatic breast cancer. Randomisation will be conducted by a 1:1 ratio.

Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer

A Randomised Phase II Pilot Study of 3 Weekly Cabazitaxel Versus Weekly Paclitaxel Chemotherapy in the First Line Treatment of HER2 Negative Breast Cancer

Defined as stable disease rate + partial response rate+complete response rate according to RECIST 1.1 criteria

Defined as complete and partial response recorded from the start of treatment to completion of 6 cycles of treatment.

Survival duration from randomisation to date of death.

time from randomisation to another chemotherapy treatment after confirmed progression.

Time taken for tumour burden to respond to treatment

University Hospitals Bristol and Weston NHS Foundation Trust

Amino Acids

Hormones

Fulvestrant

Estrogens

Mitogens

Palbociclib

Aromatase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Serine

Tyrosine

Threonine

Palbociclib, an orally active pyridopyrimidine, is a potent and highly selective reversible inhibitor of CDK 4 and CDK6. The compound prevents cellular DNA synthesis by prohibiting progression of the cell cycle from G1 into the S phase. Specifically, Palbociclib inhibits CDK4/6-catalyzed phosphorylation of the retinoblastoma protein (Rb), which is required for cell division.

Palbociclib has selectivity for CDK4/6, with little or no activity against a large panel of 274 other protein kinases including other CDKs and a wide variety of tyrosine and serine/threonine kinases.

Therapeutic indications:

Palbociclib is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or MBC:

* in combination with an aromatase inhibitor;
* in combination with fulvestrant in women who have received prior endocrine therapy.

Cristina Oprean, PI

Ramona Petrita, CSO

Cristina M Oprean, PI

Mircea Dragoș Median, PI

Nicoleta Zenovia Antone, PI

Dorina Larisa Ciule, PI

Michael Schenker, PI

Bogdan Gafton, PI

Aniela Platona, PI

Cristina Marinela Oprean, MD

PALBO is a Non-Interventional, National Study Of Real-World Evidence In Estrogen Receptor Positive, Her2 Negative Metastatic Breast Cancer Patients Treated With Palbociclib During A 2.5 Years Follow-Up Period. The primary objective is to identify pathological and clinical features of MBC that is associated with Palbociclib's best efficacy, measured by response rate (overall response rate, duration of response and best clinical response), progression free survival and OS. Safety of Palbociclib will also be evaluated.

Metastatic breast cancer (MBC) is the most advanced stage of breast cancer, where the disease has spread to distant sites beyond the axillary lymph nodes. At European level, MBC occurs in up to 20-30 percent of women diagnosed with early-stage breast cancer. At regional level, there are variations in newly diagnosed patients who present with metastatic disease. In high income countries fewer than 8% of patients are initially diagnosed with MBC, while the highest burden of MBC is carried by low and middle-income countries where up to 60% are initially diagnosed with MBC. Currently, the median overall survival for patients with MBC is approximately 2 to 3 years in developed countries, but lower in developing countries. In Romania, 8900 new cases of BC are diagnosed every year, with 80% being diagnosed in an advance stage of the disease (II, III, IV). Furthermore, after initial BC treatment, approximately 50% will develop MBC.

Cyclin-dependent kinase (CDK) 4/6 inhibitors (Palbociclib, ribociclib and abemaciclib) are now standard of care for the treatment of advanced hormone receptor positive (HR+) and HER2 negative (HER2-) breast cancer.

On 09 November 2016, the EC has approved IBRANCE® (Palbociclib) as the first CDK 4/6 inhibitor, to be used in combination with letrozol as first-line or in combination with fulvestrant in women who have received prior endocrine therapy, based on the results of PALOMA-1, PALOMA-2 and PALOMA-3 study results. Other phase III randomized trials have been reported and confirmed the efficacy of CDK4/6 inhibition in both first-line and endocrine resistant settings.

Palbociclib®, an orally active pyridopyrimidine, is a potent and highly selective reversible inhibitor of CDK 4 and CDK6. The compound prevents cellular DNA synthesis by prohibiting progression of the cell cycle from G1 into the S phase. Specifically, Palbociclib inhibits CDK4/6-catalyzed phosphorylation of the retinoblastoma protein (Rb), which is required for cell division.

Palbociclib® has selectivity for CDK4/6, with little or no activity against a large panel of 274 other protein kinases including other CDKs and a wide variety of tyrosine and serine/threonine kinases.

An approximate number of 650 patients will be included in the present study which will take place on national level in 6 sites in Romania.

Study Of Real-World Evidence In Patients Treated With Palbociclib During a 2.5 Years Follow-Up Period

Non-Interventional, National Study Of Real-World Evidence In Estrogen Receptor Positive, Her2 Negative Metastatic Breast Cancer Patients Treated With Palbociclib During a 2.5 Years Follow-Up Period

DCR will be calculated per modified Response Evaluation Criteria in Solid Tumours (mRECIST) V1.1 criterion, as the proportion of patients with best overall response to protocol therapy of complete response (CR), partial response (PR) or stable disease (SD) that is maintained for at least 12 weeks.

OS will be defined as the elapsed time from the enrolment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will at 1, 2 and 3 months until death or withdrawal of consent from the study.

ORR will be defined as the proportion of the patients with a confirmed CR or PR, as per mRECIST V1.1 criterion.

DOR will be defined as the elapsed time from documented tumour response to documented disease progression.

The first secondary objective of our study is to identify the medium duration of the treatment with aromatase inhibitors (AI) in first-line and with fulvestrant in second-line.

The second secondary objective of our study is to identify the Clinical Benefit Rate (CBR), defined as the proportion of patients with no disease progression after 6 months of therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer	NCT03048942	HER2 Negative M...	Cabazitaxel Paclitaxel	18 Years - 99 Years	University Hospitals Bristol and Weston NHS Foundation Trust
Study Of Real-World Evidence In Patients Treated With Palbociclib During a 2.5 Years Follow-Up Period	NCT05135104	Metastatic Brea...	Palbociclib	18 Years - 65 Years	Asociatia Oncohelp - Centrul de Oncologie Oncohelp

Spots Global Cancer Trial Database for her2 negative metastatic breast cancer