BridgeMD
A trial to learn more about the effects of ribociclib taken with endocrine therapy in patients with early breast cancer.
EU CTIS ID: 2022-503001-38-01
What this study is testing
To evaluate invasive Breast Cancer Free Survival (iBCFS) rate at 3-years for ribociclib + endocrine therapy (ET) in patients with HR-positive, HER2-negative early breast cancer.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant is an adult, male or female ≥ 18 years of age at the time of informed consent signature (ICF).
- Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample and all tested by a local laboratory prior to enrolment.
- Participant has HER2− BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.
- Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrolment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy. For participants with prior ET treatment >12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrolment. The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.
- Participant has no contraindication to receive adjuvant ET in the study.
- Participant after surgical resection where tumour was removed completely, with the final surgical specimen microscopic margins free from tumour, and belongs to one of the following categories: anatomic stage group III and substets of anatomic stage group II.
You likely can't join if
- Participant with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
- Participant is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET.
- Participant has any other concurrent severe and/or uncontrolled medical condition
- - Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.
See the full eligibility criteria
Who can join
- Participant is an adult, male or female ≥ 18 years of age at the time of informed consent signature (ICF).
- Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample and all tested by a local laboratory prior to enrolment.
- Participant has HER2− BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.
- Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrolment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy. For participants with prior ET treatment >12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrolment. The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.
- Participant has no contraindication to receive adjuvant ET in the study.
- Participant after surgical resection where tumour was removed completely, with the final surgical specimen microscopic margins free from tumour, and belongs to one of the following categories: anatomic stage group III and substets of anatomic stage group II.
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1 or 2.
- Participant has adequate bone marrow and organ function.
- ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as: • QTcF interval at screening < 450 msec (QT interval using Fridericia’s correction). • Mean resting heart rate 50-99 beats per minute (determined from the ECG ).
What rules you out
- Participant with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
- Participant is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET.
- Participant has any other concurrent severe and/or uncontrolled medical condition
- - Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Israel
- Turkey
- Argentina
- Taiwan
- Australia
- India
- Hong Kong
- United States
- Brazil
- Korea, Republic of
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; Israel; Turkey; Argentina; Taiwan; Australia and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.