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New treatment option for Anatomic Stage II Breast Cancer AJCC v8
Official title Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
ClinicalTrials.gov ID: NCT07391774
What this study is testing
What is Anastrozole?
Anastrozole is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for anatomic stage ii breast cancer ajcc v8.
Also referred to as Anastrazole, Arimidex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- STEP 0: Patient must be ≥ 18 years of age
- STEP 0: Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 28 days prior to Step 0 pre-registration
- STEP 0: Patient must be a postmenopausal woman or a man
- NOTE: Menopause can be determined by any of the following:
- Prior bilateral oophorectomy
See the full eligibility criteria
Who can join
- STEP 0: Patient must be ≥ 18 years of age
- STEP 0: Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 28 days prior to Step 0 pre-registration
- STEP 0: Patient must be a postmenopausal woman or a man
- NOTE: Menopause can be determined by any of the following:
- Prior bilateral oophorectomy
- Age ≥ 60 years
- Age \< 60 years with amenorrhea for ≥ 12 months and estradiol and follicle stimulating hormone (FSH) levels in the postmenopausal range
- NOTE: FSH and estradiol levels should be repeated as clinically indicated to ensure menopausal status in patients with breast cancer with chemotherapy-induced amenorrhea
- STEP 0: Patient must meet one of the following staging criteria postoperatively according to American Joint Committee on Cancer (AJCC) 8th edition criteria
- pT0-T3 with 3 positive ipsilateral lymph nodes (micro-or macrometastatic disease) and no planned axillary lymph node dissection after definitive surgery in the breast and axilla with curative intent.
- pT0-T3 with N2 or N3
- pT3 with N0-N3
- NOTES:
- Patients with T4 breast cancer are not eligible.
- Positive isolated tumor cells (ITCs) in axillary nodes without micro- or macrometastasis are considered N0 for eligibility purposes.
- ITC does not contribute to nodal count for staging purposes
- STEP 0: Patient must have a primary breast tumor that is estrogen receptor (ER) positive with \> 10% ER expression by immunohistochemistry (IHC) as per 2020 American Society of Clinical Oncology (ASCO)/College of...
- NOTE: ER 1-10% are reported as ER low positive. These tumors have less endocrine-sensitive disease and are not eligible)
- STEP 0: Patient must have a primary breast tumor that is HER2-negative by current ASCO/CAP guidelines utilizing immunohistochemistry and/or fluorescence in situ hybridization (FISH)
- STEP 0: Patient may have multicentric or multifocal breast cancer if the highest stage tumor meets eligibility criteria outlined above, and the tumor sites are felt to represent a single disease process by local...
- STEP 0: For patients who have undergone a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local...
- STEP 0: For patients who have undergone mastectomy, the margins must be free of residual gross tumor. Patients with microscopic positive margins are eligible if post-mastectomy radiation treatment (RT) of the chest wall...
- STEP 0: Patient must have undergone axillary staging with sentinel lymph node biopsy (SLNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND)
- STEP 0: Patient must have no evidence of locoregional or distant metastatic disease by clinical history and physical exam. Treating physician can consider additional imaging evaluation per National Comprehensive Cancer...
- STEP 0: Patient must be able to have Oncotype DX testing performed.
- If Oncotype DX testing was previously performed, the results of Recurrence Score (RS) must be available and must meet Step 1 eligibility criteria.
- If Oncotype DX testing was not performed yet, tissue from the core, excisional biopsy or surgical specimen of the tumor lesion must be available and must be shipped to Exact Sciences for determination of the Oncotype DX...
- NOTE: Exact Sciences will notify the submitting institution of Recurrence Score results within two (2) weeks of receipt of the tumor specimen. Institutions will receive an email notification of eligibility status once...
- STEP 0: Patient must have had their final cancer surgery for breast cancer (including re-excision of margins) less than 16 weeks prior to Step 0 Pre-Registration.
- NOTE: This excludes additional surgery for reconstructive purposes
- STEP 0: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are...
- STEP 0: Patients with synchronous DCIS or LCIS are eligible
- STEP 0: Patient with prior history of ER-negative DCIS diagnosed at least 5 years prior to Step 0 Pre-Registration without evidence of recurrence are eligible
- STEP 0: Patient must not have a prior history of invasive ER-positive breast cancer. Patients with a history of ER-negative breast cancer are eligible if they were diagnosed at least 5 years prior to Step 0...
- STEP 0: Patients must not have received prior endocrine therapy such as tamoxifen, raloxifene, or aromatase inhibitors for chemoprevention within 5 years prior to Step 0 Pre-Registration with the exception of a short...
- NOTE: The Oncotype Dx for study eligibility must be performed on specimen obtained prior to initiation of any endocrine therapy
- STEP 0: Patient must not be concurrently using systemic hormone replacement therapy (HRT). If receiving HRT at the time of breast cancer diagnosis, this must be discontinued prior to Step 0 Pre-Registration with...
- STEP 0: Absolute neutrophil count (ANC) ≥ 1,500/µL (obtained ≤ 28 days prior to Step 0 Pre-Registration)
- STEP 0: Hemoglobin ≥ 9.0 g/dL (obtained ≤ 28 days prior to Step 0 Pre-Registration)
- STEP 0: Platelets ≥ 100,000/µL (obtained ≤ 28 days prior to Step 0 Pre-Registration)
- STEP 0: Total bilirubin ≤ institutional upper limit of normal (ULN) or \< 1.5 x ULN for patients who have a bilirubin elevation in patients with well documented Gilbert's disease or similar syndrome involving slow...
- STEP 0: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 × institutional ULN (obtained ≤ 28 days...
- STEP 0: Estimated glomerular filtration rate (eGFR) ≥ 30 mL/minute/1.73 m\^2 (obtained ≤ 28 days prior to Step 0 Pre-Registration)
- STEP 0: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 Pre-Registration are eligible for this trial
- STEP 0: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- STEP 0: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- STEP 0: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart...
- STEP 0: Patient must have a standard 12-lead electrocardiogram (ECG) within 28 days prior to Step 0 Pre-Registration, documenting:
- QT interval using Fridericia's correction (QTcF) \< 450 msec.
- Resting heart rate 50-90 beats per minute (determined from the ECG)
- STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative...
- STEP 0: Patient must not have comorbidities considered a safety risk for standard adjuvant chemotherapy, endocrine therapy or CDK4/6 inhibitor as per Investigator's discretion
- STEP 0: Patient must not have a contraindication to adjuvant chemotherapy based on treating physician's discretion
- STEP 0: Patient must not have received prior chemotherapy for this malignancy
- STEP 0: Patient must not have received prior CDK4/6 inhibitor
- STEP 0: Patient must not have a known contraindication to ribociclib per current Food and Drug Administration (FDA) indication
- STEP 0: Patient must not have a known hypersensitivity to any of the excipients of ribociclib and/or endocrine therapy (ET) (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency...
- STEP 0: Males must not expect to father children and males and their partners must be willing to use highly effective methods of contraception while on protocol treatment. Males must not donate sperm while on protocol...
- Intrauterine device
- Bilateral tubal occlusion
- Vasectomized partner
- Sexual abstinence If the highly effective contraceptive methods are contraindicated or strictly declined by the patient, or in the event of sexual activity of low frequency, a combination of male condom with cap...
- STEP 1: Patient must meet all Step 0 Pre-Registration eligibility criteria at the time of their Step 1 randomization
- STEP 1: Patient must not have had any major surgery or radiotherapy within 14 days prior to Step 1 randomization
- STEP 1: Patient must have a Recurrence Score (RS) of 0-25 from Oncotype DX testing from diagnostic biopsy or surgical specimen as reported by the Exact Sciences assay
The study team makes the final eligibility decision.
Where it's taking place
- Jonesboro, Arkansas, United States
- Berkeley, California, United States
- Palo Alto, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- San Mateo, California, United States
- Vallejo, California, United States
- Stamford, Connecticut, United States
- Newark, Delaware, United States
- Coeur d'Alene, Idaho, United States
- Post Falls, Idaho, United States
- Sandpoint, Idaho, United States
- Bloomington, Illinois, United States
- Canton, Illinois, United States
- Carterville, Illinois, United States
- Carthage, Illinois, United States
- Decatur, Illinois, United States
- Eureka, Illinois, United States
- Galesburg, Illinois, United States
+ 35 more site(s).
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jonesboro, Arkansas, United States; Berkeley, California, United States; Palo Alto, California, United States; Roseville, California, United States; Sacramento, California, United States; San Francisco, California, United States and 49 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 ClinicalTrials.gov; the study team decides eligibility.