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New treatment option for Premenopausal Breast Cancer
Official title Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC
ClinicalTrials.gov ID: NCT05720260
What this study is testing
What is Goserelin?
Goserelin is an investigational medicine, being studied as a potential treatment for premenopausal breast cancer.
Also referred to as GnRH agonist.
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 an open-label randomized phase II study in estrogen receptor positive locally advanced or metastatic breast cancer patients. The main inclusion population are either luminal subtype B by PAM50 analysis or failed less than 2 lines of hormonal therapy for locally advanced or metastatic breast cancer.
- Phase 2: a mid-size study of how well it works
- 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 20 and older, women only
You may be able to join if
- A histological confirmed ER positive (\>1%) invasive breast cancer.
- Locally advanced or metastatic disease with at least one measurable target lesion
- Patients who had not received chemotherapy for locally advanced or metastatic disease
- Patients have to be (i) either primary resistant to hormonal therapy defined as recurrence developed within 2 years of adjuvant hormonal therapy (ii)...
- Patients must be premenopausal or perimenopausal women according the clinical menstrual history or E2 / FSH level based on local hospital guidance...
You likely can't join if
- Patients fulfilled ANY of the following criteria will be excluded from this trial:
- Prior therapy with capivasertib, fulvestrant, anti-PD1 or anti-PDL1 immunotherapy
- Prior chemotherapy for locally advanced or metastatic breast cancer.
- Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment
- The tumor is HER-2 positive by IHC 3+ or IHC 2+/ISH positive.
- Patients have active brain metastases or spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring...
See the full eligibility criteria
Who can join
- A histological confirmed ER positive (\>1%) invasive breast cancer.
- Locally advanced or metastatic disease with at least one measurable target lesion
- Patients who had not received chemotherapy for locally advanced or metastatic disease
- Patients have to be (i) either primary resistant to hormonal therapy defined as recurrence developed within 2 years of adjuvant hormonal therapy (ii) or resistant to prior hormonal therapy (failed ≤ 2lines of hormonal...
- Patients must be premenopausal or perimenopausal women according the clinical menstrual history or E2 / FSH level based on local hospital guidance. Patient with menopausal status cannot be determined due to ongoing LHRH...
- ECOG 0-1
- Patients must have adequate organ and marrow reserve measured within 14 days(within screening period ) prior to randomization as defined below:
- Hemoglobin ≥ 9.0 g/dL;
- Absolute neutrophil count ≥ 1,500 /L;
- Platelets ≥ 100,000/L;
- Total bilirubin ≤ 1.5 x upper normal limit;
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x upper normal limit; for patients with liver metastases AST(SGOT)/ALT(SGPT) ≤ 5 x upper normal limit is allowed;
- Serum creatinine ≤ 1.5mg/dL or creatinine clearance ≧50ml/min;
- aPTT \< 1.5 x upper normal limit (unless on therapeutic anti-coagulation);
- Proteinuria ≤ 1+ with urine dipstick, if \> 1+, 24-hour urine protein must be ≤ 1 g.
- Age older than 20-year-old.
- All women of childbearing potential must have a negative pregnancy test obtained within 7 days before starting therapy. Patients must not be breastfeeding.
- Patients with reproductive potential must use effective contraception (hormone or barrier method of birth control) prior to study entry, for the duration of study participation, and for 6 months after the completion of...
- Patients (or a surrogate) must be able to comply with study procedures and to give signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and...
- Body weight \>30 kg
- Must have a life expectancy of at least 12 weeks
What rules you out
- Patients fulfilled ANY of the following criteria will be excluded from this trial:
- Prior therapy with capivasertib, fulvestrant, anti-PD1 or anti-PDL1 immunotherapy
- Prior chemotherapy for locally advanced or metastatic breast cancer.
- Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment
- The tumor is HER-2 positive by IHC 3+ or IHC 2+/ISH positive.
- Patients have active brain metastases or spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment
- Other malignancy within 5 years except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.
- Psychiatric illness or social situation that would preclude study compliance.
- Serious non-healing wound, ulcer, or bone fracture.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.
- Prior minor surgery within 7 days.
- History of allergic reaction to compounds of similar chemical composition to the study drugs.
- Pregnancy or lactation.
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV...
- Known to have tested positive for human immunodeficiency virus
- History of allogenic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus...
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial...
- History of another primary malignancy except for: a) Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence; b) Adequately...
- History of leptomeningeal carcinomatosis.
- Previous allogeneic bone marrow transplant or solid organ transplant.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed \ \> of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
- Any of the following cardiac criteria at screening:
- Mean resting corrected QT interval (QTc) \>470 msec obtained from 3 consecutive ECGs
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block)
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome...
- Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York...
- Uncontrolled hypotension - SBP \<90 mmHg and/or DBP \<50 mmHg
- Cardiac ejection fraction outside institutional range of normal or \<50% (whichever is higher) as measured by echocardiogram.
- Clinically significant abnormalities of glucose metabolism as defined by any of the following at screening:
- Patients with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment
- HbA1c ≥8.0% (63.9 mmol/mol)
- Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment
- Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort), or sensitive substrates of CYP3A4, CYP2C9 and/or CYP2D6 with a narrow therapeutic window...
- Participation in another clinical study with an investigational medicinal product (IMP) administered in the last 30 days or 5 half-lives, whichever is longer
- History of hypersensitivity to active or inactive excipients of capivasertib, fulvestrant, durvalumab, goserelin or drugs with a similar chemical structure or class to the above-mentioned drugs
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
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 female, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. 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.