Breast CancerPhase 3RainbowNCT06341621
Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib
A Phase 3 study testing 3-year abemaciclib without chemo and treatment of physician's choice in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 3-year abemaciclib without chemo and treatment of physician's choice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,900 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2024to 1 Jan 2029
- Phase
- Phase 3
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women aged 18-80 years old;
- Patient has localized invasive breast carcinoma with1-3 positive lymph nodes, T1-T2，and is ER+/HER2- confirmed by histopathology after early breast cancer surgery#HER2-negative breast cancer (based on most recently analyzed biopsy) 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 (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH) .
- ER≥50%
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 * 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤
- 1×ULN#and with endogenous creatinine clearance rate of >50 ml/min (Cockcroft-Gault formula).
- Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.
Who cannot join
- Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy#;
- Has bilateral breast cancer;
- Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
- Has metastatic (Stage 4) breast cancer;
- Has any ≥T3 lesion
- Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives;
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- Patients participating in other clinical trials at the same time;
- Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) < 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension;
- Has severe or uncontrolled infection;
- the researchers judged patients to be unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhimin Cancer Shao
Shanghai, 200032
Zhimin Shao, MD, PhD, +8664175590, zhimingshao@yahoo.com
Yin Liu, MD, +8664175590, liuyinfudan@163.com
About this study
Official title: A Prospective, Randomized, Open-label, Multicenter Phase III Study to Explore Chemotherapy Omission in ER+/HER2-endocrine-sensitive Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib
Read the detailed description
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib. In this study, patient eligible will be randomized into either endocrine drug plus 3-year adjuvant abemaciclib without chemotherapy or treatment of physician's choice (TPC).The safety and efficacy of each group will be assessed through invasive disease free survival (iDFS), disease-free survival (DFS), distant disease free survival (DDFS), overall survival (OS) and adverse effects (AE) as graded by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
- Conditions
- Breast Cancer
- Being tested
- 3-year abemaciclib without chemo, treatment of physician's choice
- Keywords
- adjuvant chemotherapy omission, adjuvant abemeciclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-year abemaciclib without chemoDrug
aromatase inhibitors (± ovarian suppression) plus 3-year abemaciclib (100mg bid) without chemotherapy.
treatment of physician's choiceDrug
treatment of physician's choice including whether to receive chemotherapy, chemotherapy regimen and endocrine therapy regimen.
| Study group | Role | What they receive |
|---|---|---|
| endocrine drug plus 3-year abemaciclib without chemo | Experimental | aromatase inhibitors with or without GnRHa plus 3-year lower dose (100mg bid) abemaciclib without chemotherapy. Receives: Drug: 3-year abemaciclib without chemo |
| treatment of physician's choice | Active comparator | treatment of physician's choice, including whether to receive chemotherapy, the chemotherapy regimen and the endocrine therapy regimen. Receives: Drug: treatment of physician's choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive disease free survival
Measured: 5 year
Secondary outcomes (4)
disease free survival
Measured: 5 year
distant disease free survival
Measured: 5 year
overall survival
Measured: 5 year
Time Frame: 5 years] 5. adverse effects adverse effects
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start2 Apr 2024
- Primary completion25 Feb 2027 (estimated)
- Study completion1 Jan 2029 (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.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1# endocrine drug plus 3-year abemaciclib without chemotherapy Arm 2# treatment of physician's choice
- Masking
- None (open label)
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhimin Shao, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341621
- Sponsor's protocol ID
- SCHBCC-N071
- Acronym
- Rainbow
- Status last verified
- Apr 2024
- First submitted
- 16 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-label, Multicenter Phase III Study to Explore Chemotherapy Omission in ER+/HER2-endocrine-sensitive Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib
- ClinicalTrials.gov ID
- NCT06341621
- Acronym / sponsor ID
- Rainbow / SCHBCC-N071
- Conditions
- Breast Cancer
- Keywords
- adjuvant chemotherapy omission, adjuvant abemeciclib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 2 Apr 2024 (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.
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib
Detailed description
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib. In this study, patient eligible will be randomized into either endocrine drug plus 3-year adjuvant abemaciclib without chemotherapy or treatment of physician's choice (TPC).The safety and efficacy of each group will be assessed through invasive disease free survival (iDFS), disease-free survival (DFS), distant disease free survival (DDFS), overall survival (OS) and adverse effects (AE) as graded by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1# endocrine drug plus 3-year abemaciclib without chemotherapy Arm 2# treatment of physician's choice
| Arm | Type | Receives |
|---|---|---|
| endocrine drug plus 3-year abemaciclib without chemo | Experimental | Drug: 3-year abemaciclib without chemoaromatase inhibitors with or without GnRHa plus 3-year lower dose (100mg bid) abemaciclib without chemotherapy. |
| treatment of physician's choice | Active comparator | Drug: treatment of physician's choicetreatment of physician's choice, including whether to receive chemotherapy, the chemotherapy regimen and the endocrine therapy regimen. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- women aged 18-80 years old;
- Patient has localized invasive breast carcinoma with1-3 positive lymph nodes, T1-T2，and is ER+/HER2- confirmed by histopathology after early breast cancer surgery#HER2-negative breast cancer (based on most recently analyzed biopsy) 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 (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH) .
- ER≥50%
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 * 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤
Key exclusion criteria (10 listed)
- Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy#;
- Has bilateral breast cancer;
- Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ.
- Has metastatic (Stage 4) breast cancer;
- Has any ≥T3 lesion
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 |
|---|---|---|
| 3-year abemaciclib without chemoaromatase inhibitors (± ovarian suppression) plus 3-year abemaciclib (100mg bid) without chemotherapy. | Drug | endocrine drug plus 3-year abemaciclib without chemo |
| treatment of physician's choicetreatment of physician's choice including whether to receive chemotherapy, chemotherapy regimen and endocrine therapy regimen. | Drug | treatment of physician's choice |
Primary outcome
Invasive disease free survival
Time frame: 5 year
4 secondary outcomes
disease free survival
Time frame: 5 year
distant disease free survival
Time frame: 5 year
overall survival
Time frame: 5 year
Time Frame: 5 years] 5. adverse effects adverse effects
Time frame: 5 year
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 10 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Zhimin Shao, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 3-year abemaciclib without chemo and treatment of physician's choice in people with Breast Cancer, run by Fudan University at 1 site in China.
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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 10 Apr 2024. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhimin Shao, MD, PhD (+86-021-64175590 ext. 8808, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive disease free survival (time frame: 5 year). 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 10 Apr 2024.