BridgeMD
New treatment option for Breast Cancer
Official title Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT05524584
What this study is testing
What is Fulvestrant?
Fulvestrant is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for breast cancer.
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 is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer. These are subjects who are newly diagnosed advanced or metastatic hormone receptor positive breast cancer or subjects who have progressed following treatment free interval of more than 12 months following adjuvant or neoadjuvant treatment.
- Phase 2: a mid-size study of how well it works
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
- Patients must have a diagnosis of HR+ breast cancer. To fulfill the requirement of HR+ disease, a breast cancer must express, by immunohistochemistry...
- Patients must have newly diagnosed metastatic regional breast cancer (Stage IV per AJCC 8th edition criteria for staging of breast cancer) or...
- Age ≥ 18 years
- ECOG performance status 0-2
- Have post-menopausal status as defined by following: Prior bilateral oophorectomy. Age ≥ 60 years, Age \< 60 and amenorrheic (non-treatment-induced...
You likely can't join if
- Localized breast cancer which is curable with surgery or radiation, with or without chemotherapy. This study will utilize the American Joint...
- Current diagnosis of inflammatory breast cancer
- Patients who have had chemotherapy or radiotherapy within 12 months prior to entering the study. (Note: Palliative radiotherapy is does not require a...
- Prior treatment with Fulvestrant (Note: For the current diagnosis, fulvestrant initiated within 8 weeks prior to starting study intervention is...
- Patients are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged by the...
- Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example...
See the full eligibility criteria
Who can join
- Patients must have a diagnosis of HR+ breast cancer. To fulfill the requirement of HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least one of the hormone receptors (ER, progesterone...
- Patients must have newly diagnosed metastatic regional breast cancer (Stage IV per AJCC 8th edition criteria for staging of breast cancer) or local-regional advanced or recurrent cancer not amenable to curative...
- Age ≥ 18 years
- ECOG performance status 0-2
- Have post-menopausal status as defined by following: Prior bilateral oophorectomy. Age ≥ 60 years, Age \< 60 and amenorrheic (non-treatment-induced amenorrhea secondary to tamoxifen, toremifene, ovarian suppression, or...
- Have at least one measurable disease as defined per RECIST 1.1
- Adequate organ and marrow function as defined below:
- Hemoglobin \>8 g/dL. Patients may receive transfusion of packed red blood cells (PRBC) to achieve this hemoglobin level at the discretion of the investigator; however, initial study drug treatment must not begin earlier...
- Absolute neutrophil count ≥1,500/mcL
- Platelets ≥ 100,000/mcl
- Total bilirubin ≤ 1.5 X institutional ULN. Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted
- AST (SGOT)/ALT (SPGT) ≤ 2.5 X institutional ULN
- Creatinine ≤ 1.5 X institutional ULN
- Able to swallow oral medications
- Patients who received chemotherapy or curative radiotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy and curative radiotherapy except...
- Person of child bearing potential (POCBP) (ie. premenopausal) and men must agree to use ovarian or testicular suppression prior to study entry, for the duration of study participation, and for 90 days following...
- A post-menopausal female patient is defined by one of the following for female patients: prior bilateral oophorectomy, age ≥ 60 years, age \< 60 and amenorrheic (non-treatment-induced amenorrhea secondary to tamoxifen...
- If follicle-stimulating hormone (FSH) and estradiol labs were performed as standard practice within the screening window and the patient is post-menopausal, those lab results must be in the postmenopausal range. These...
- POCBP are required to initiate effective contraception by study intervention start. Effective contraception is per the investigator's discretionhild. A POCBP (regardless of sexual orientation, having undergone a tubal...
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Must be able to sign a written informed consent, are reliable, willing to be available for the duration of the study and are willing to follow study procedures.
- Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.
What rules you out
- Localized breast cancer which is curable with surgery or radiation, with or without chemotherapy. This study will utilize the American Joint Committee on Cancer (AJCC) staging system, eight edition that provides a...
- Current diagnosis of inflammatory breast cancer
- Patients who have had chemotherapy or radiotherapy within 12 months prior to entering the study. (Note: Palliative radiotherapy is does not require a washout Note: For current diagnosis, CDK 4/6 inhibitor and/or...
- Prior treatment with Fulvestrant (Note: For the current diagnosis, fulvestrant initiated within 8 weeks prior to starting study intervention is allowed)
- Patients are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged by the investigator not to be scientifically or medically compatible with this...
- Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel...
- Have a personal history of any of the following conditions: syncope or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation or sudden cardiac arrest
- Have a history of any other cancer (except for non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission with no therapy for a minimum of three years or have received an autologous or...
- Have an active bacterial or fungal infection or a detectable viral infection (for example HIV or viral hepatitis). Screening is not required for enrollment
- Recent therapy with a biologic agent or a monoclonal therapy is excluded. Wash out of at least three half-lives of monoclonal antibody would be required to be enrolled.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CDK4/6 inhibitors or other agents used in study.
- Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
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 Orange, California, United States. 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.