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Breast Diseases

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Ribociclib 600mg p.o. d1-21, q4w in combination with endocrine treatment for 3 years.

Ribociclib

mono-chemotherapy for at least 12 weeks (afterwards, maintenance endocrine therapy ± ribociclib inhibitor is allowed) and up to 3 years.

Mono-chemotherapy

The choice of endocrine therapy is up to the investigator, but the chosen endocrine therapy has to be registered to be used in combination with ribociclib in the investigated indication.

Endocrine-Therapy

Thomas Ruhstaller, Prof

The aim of this trial is to assess if patients treated with the combination of ribociclib and endocrine therapy respond to treatment as fast as patients treated with chemotherapy only, without decreasing their quality of life (QoL).

Breast cancer is the most frequent malignancy in women and the leading cause of cancer mortality in most countries in Europe. Metastatic breast cancer remains an incurable disease with a median overall survival (OS) of 2-4 years and a 5-year survival of only 25%. Patients with hormone receptor (HR)-positive breast cancer involving visceral disease at diagnosis have an even worse outcome.

Many oncologists still prefer to treat visceral disease primarily with chemotherapy rather than with endocrine treatment, thinking to receive a faster response with chemotherapy than with endocrine therapy, especially in patients with clinical symptoms or potentially threatening lesions. However, results from cross-sectional clinical practice studies suggest that endocrine therapy is associated with better quality of life, fewer concerns about side effects, less activity impairment and higher treatment satisfaction compared to chemotherapy. In addition, with the new data of CDK4/6 inhibitors combined with endocrine treatment there is an even better efficacy data available compared to endocrine therapy alone.

The aim of this trial is to assess if patients treated with the combination of ribociclib and endocrine therapy respond to treatment as fast as patients treated with chemotherapy only, without decreasing their quality of life (QoL).

This is an international, multicenter, open-label, randomized phase III trial.

Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line in Visceral mBC

Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line Treatment in Patients With Visceral Metastatic Breast Cancer. A Multicenter, Randomized Phase III Trial.

A patient will be counted as a success for this endpoint when during the first 12 weeks

- the response according to RECIST v1.1 is stable disease or better.

A patient will be counted as a success for this endpoint when during the first 12 weeks

- the QoL according Functional Assessment of Cancer Therapy-Breast Trial Outcome Index \[FACT-B TOI\] score does not worsen by 5 points or more.

A patient will be counted as a success for this endpoint when during the first 12 weeks the response according to RECIST v1.1 is stable disease or better. Patients with missing response assessments within the first 12 weeks will be counted as failure unless there was no progressive disease (PD) documented within the first 12 weeks and the first subsequent assessment also shows no PD

ORR is defined as the proportion of patients having achieved complete response (CR) or partial response (PR) during trial treatment. Response will be evaluated according to RECIST v1.1 criteria.

Time to OR will be calculated from randomization until first documented CR or PR according to RECIST v1.1 criteria. Time to OR will be calculated for patients having achieved a CR or PR at any time during trial treatment.

PFS is defined as the time from randomization until progression according the RECIST v1.1 criteria or death from any cause, whichever occurs first. Patients not having an event at the time of analysis as well as patients starting a new anti-cancer therapy in the absence of an event will be censored at the date of their last tumor assessment before starting a new anti-cancer treatment, if any.

TTF is defined as the time from randomization until stopping of trial treatment from any cause. Patients not having an event at the time of analysis will be censored at the date of their last known date of trial treatment.

OS at 3 years is determined by the Kaplan-Meier estimator for OS at 3 years. OS is defined as time from randomization to death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.

Changes in Functional Assessment of Cancer Therapy-Breast (FACT-B) total score (score range 0-148, higher scores indicate better quality of life)

Time to QoL deterioration is defined as the duration between baseline and first occurrence of a decrease of ≥ 5 points in the FACT-TOI score.

Time to QoL improvement is defined as the duration between baseline and first occurrence of an increase of ≥ 5 points in the FACT-TOI score.

Improvements in pain will be assessed up to 24 months by the item pain severity of the Brief Pain Inventory (BPI), scale range: 0= no pain to 10 = pain as bad as one can imagine.

All AEs will be assessed according to NCI CTCAE v5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line in Visceral mBC	NCT03905343	Breast Cancer	Ribociclib Mono-chemothera... Endocrine-Thera...	18 Years -	Swiss Group for Clinical Cancer Research
Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line in Visceral mBC	NCT03905343	Breast Cancer	Ribociclib Mono-chemothera... Endocrine-Thera...	18 Years -	Swiss Group for Clinical Cancer Research

Spots Global Cancer Trial Database for visceral metastatic breast cancer