None listed
Conditions
Brief summary
Who is it for? This study will investigate the safety and efficacy of Stereotactic Radiotherapy treatment in combination with aromatase inhibitor and cyclin-dependent kinase (CDK) 4/6 inhibitor for metastatic breast cancer." You may be eligible to join this study if you are aged 18 and above, have histologically proven ER-positive, HER2-negative advanced breast cancer with metastases and receiving an aromatase inhibitor in combination with a CDK 4/6 inhibitor Study details All participants in this study receive stereotactic radiotherapy (between 1 -5 doses as ascertained by treating Doctor after consultation) in combination with prescribed aromatase inhibitor and CDK 4/6 inhibitor. Participants will be monitored for reactions and treatment effectiveness, and provide blood and urine for analysis throughout the 2 year study. This research will give us information about whether adding radiotherapy to a CDK 4/6 inhibitor increases the amount of time participants can stay on CDK 4/6 inhibitor therapy.
Interventions
Patients who are receiving an Aromatase Inhibitor in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor for at least 6 months, will be offered Stereotactic Radiotherapy for up to 5 oligoprogressive lesions.
Stereotactic Radiotherapy will be given preferably as 1 dose of 20Gy, if this isn't suitable then it can be given over 3 days at 10Gy per day or over 5 days at 7Gy per day.
The radiotherapy will be given during the week off CDK4/6 inhibitor and the patient must stop this at least
Patients who are receiving an Aromatase Inhibitor in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor for at least 6 months, will be offered Stereotactic Radiotherapy for up to 5 oligoprogressive lesions. Stereotactic Radiotherapy will be given preferably as 1 dose of 20Gy, if this isn't suitable then it can be given over 3 days at 10Gy per day or over 5 days at 7Gy per day. The radiotherapy will be given during the week off CDK4/6 inhibitor and the patient must stop this at least 3 days before radiotherapy and not begin again until 3 days after it ends.
Sponsors
Peter Mac Callum Cancer Centre
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, 18 years of age or older 2. Patients with histologically proven ER-positive, HER2-negative advanced breast cancer receiving an AI in combination with a CDK 4/6 inhibitor. Biopsy of metastatic disease if technically feasible but not mandatory. 3. Patients must have evidence of extracranial metastatic disease with or without intracranial metastases. 4. Radiological evidence of stable or responding disease to an AI in combination with a CDK 4/6 inhibitor for a period of at least 6 months prior to study entry. (Patient must have ongoing stability/response in at least one lesion at the time of registration). 5. Evidence of new or existing OPD in 1-5 lesions. With reference to RECIST 1.132 and or PERCIST 1.033, OPD is defined as follow: a. Using CT for intracranial or extracranial OPD: i. greater than 5 mm increase in the diameter of an existing lesion OR ii. more than 20% increase in the diameter of an existing lesion on 2 consecutive imaging studies at least 2 months apart OR iii. The appearance of one or more new soft tissue lesions, measuring more than 5 mm. b. Using Positron Emission Tomography for extracranial OPD: i. greater than 30% increase in 18F-FDG SUV peak, with more than 0.8 SUV units increase in tumour SUV from the baseline scan in pattern typical of tumour and not of infection/treatment effect OR ii. New 18F-FDG avid lesions typical of cancer (including new bone lesion) and not related to treatment effect and/or infection. 6. For patients with liver or lung metastases, maximum of 3 oligoprogressive lesions in single organ. 7. All OPD must be amenable to SRT. a. Patients with risk of bone fracture are not candidate for SRT 8. For patients with intracranial metastases, SRT is the preferred treatment option, however, if clinical assessment indicated that upfront surgery is better, then post-operative SRT to the surgical cavity is recommended. 9. ECOG performance status 0-2. 10. Life expectancy of greater than 6 months. 11. Provision of written informed consent. 12. Clinician and participant are willing to continue current line of therapy.
Exclusion criteria
1. Pregnancy or lactation at the time of study entry. 2. Evidence of more than one clone of metastatic disease e.g. ER-positive and ER-negative and or HER2-positive disease. (To exclude those with some ER-positive and some TNBC or HER2-positive disease). 3. Evidence of Leptomeningeal disease. 4. Evidence of Malignant cord compression. 5. Previous chemotherapy for metastatic disease (chemo for primary breast cancer is allowed). 6. Contraindication to radiotherapy. 7. Previous radiotherapy in which the treated area planned to receive treatment is greater or equal to EQD2 40 Gy. 8. Any condition deeming the patient unsuitable to comply with the study.
Outcome results
None listed