Advanced Hormone Receptor Positive (HR+) Breast CancerNCT05108740
MAP Treatment Plan With Afinitor for Postmenopausal Women With Advanced HR+ Breast Cancer
A study testing everolimus in people with Advanced Hormone Receptor Positive (HR+) Breast Cancer, run by Novartis Pharmaceuticals.
Trial summary
The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide guidance to the Physician for the treatment and monitoring of patients in the Cohort MAP. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Advanced Hormone Receptor Positive (HR+) Breast Cancer
- What is being tested?
- everolimus
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:
- Patient has histological or cytological confirmation of hormone-receptor positive (HR+) breast cancer.
- Patient is a postmenopausal woman: Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- Patient has recurrence or progression of their cancer after treatment with Femara® (letrozole) or Arimidex® (anastrozole).
- Patient is willing to be treated with concomitant exemestane.
- Patient has adequate bone marrow and coagulation function as shown by: absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; platelets ≥ 100 × 10^9/L; hemoglobin (Hgb) ≥ 9.0 g/dL.
Show all 13Show fewer
- Patient has adequate liver function as shown by:
- Total serum bilirubin ≤ 2.0 mg/dL,
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN (or ≤ 5x ULN in patients with liver metastases),
- INR ≤2.
- Patient has adequate renal function as shown by serum creatinine ≤ 1.5 × ULN.
- Patient has fasting serum cholesterol ≤ 300mg/dL or 7.75 mmol/L and fasting triglycerides ≤ 2.5 × ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
- Patient will give a written informed consent obtained according to local guidelines.
Who cannot join
- Patients eligible for this Treatment Plan must not meet any of the following criteria:
- History of hypersensitivity to any drugs or metabolites of similar chemical classes as the product.
- Patient has HER2- overexpression confirmed by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
- Patient requires chemotherapy for symptomatic visceral disease.
- Patient is currently receiving hormone replacement therapy.
- Patient has had prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, deforolimus).
Show all 17Show fewer
- Patient has a known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus).
- Patient is receiving treatment with systemic corticosteroids or other immunosuppressive agents.
- Patient with a known history of HIV seropositivity.
- Patient has uncontrolled diabetes as defined by fasting serum glucose >1.5× ULN despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout participation in the program and adjusted as necessary.
- Patient has any severe and/or uncontrolled medical conditions such as:
- Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to randomization, serious uncontrolled cardiac arrhythmia,
- Active or uncontrolled severe infection,
- Liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA),
- Known severely impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air),
- Active, bleeding diathesis.
- Patient is unwilling to or unable to comply with the treatment plan.
About this study
Official title: Managed Access Program (MAP) Cohort Treatment Plan CRAD001Y2002M to Provide Access to Afinitor for Patients With Advanced Hormone Receptor Positive (HR+) Breast Cancer
The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide guidance to the Physician for the treatment and monitoring of patients in the Cohort MAP.
Read the detailed description
Prior to inclusion of a patient in the Cohort, the requesting Physician must submit a request for access to the product in GEMS (Grants, External Requests and Managed Access System) accessible through https://www.novartis.com/our-focus/healthcare-professionals/managedaccess-programs providing the rationale for the request and relevant medical history of the patient.
The request is then assessed against the MAP and Cohort inclusion/exclusion criteria by the medical team experienced with the product and indication. Upon the required approvals, the patient is included in the Cohort.
- Being tested
- everolimus
- Keywords
- Breast Cancer, MAP, Hormone receptor positive, Afinitor, everolimus
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimusDrug
Also called Afinitor
Self-administered as a daily dose of 10mg orally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hormone Receptor Positive (HR+) Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108740
- Sponsor's protocol ID
- CRAD001Y2002M
- Status last verified
- Nov 2021
- First submitted
- 9 Sep 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managed Access Program (MAP) Cohort Treatment Plan CRAD001Y2002M to Provide Access to Afinitor for Patients With Advanced Hormone Receptor Positive (HR+) Breast Cancer
- ClinicalTrials.gov ID
- NCT05108740
- Acronym / sponsor ID
- CRAD001Y2002M
- Keywords
- Breast Cancer, MAP, Hormone receptor positive, Afinitor, everolimus
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 5 Nov 2021 (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.
The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide guidance to the Physician for the treatment and monitoring of patients in the Cohort MAP.
Detailed description
Prior to inclusion of a patient in the Cohort, the requesting Physician must submit a request for access to the product in GEMS (Grants, External Requests and Managed Access System) accessible through https://www.novartis.com/our-focus/healthcare-professionals/managedaccess-programs providing the rationale for the request and relevant medical history of the patient.
The request is then assessed against the MAP and Cohort inclusion/exclusion criteria by the medical team experienced with the product and indication. Upon the required approvals, the patient is included in the Cohort.
Study design
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:
- Patient has histological or cytological confirmation of hormone-receptor positive (HR+) breast cancer.
- Patient is a postmenopausal woman: Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- Patient has recurrence or progression of their cancer after treatment with Femara® (letrozole) or Arimidex® (anastrozole).
- Patient is willing to be treated with concomitant exemestane.
Key exclusion criteria (17 listed)
- History of hypersensitivity to any drugs or metabolites of similar chemical classes as the product.
- Patient has HER2- overexpression confirmed by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
- Patient requires chemotherapy for symptomatic visceral disease.
- Patient is currently receiving hormone replacement therapy.
- Patient has had prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, deforolimus).
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 |
|---|---|---|
| everolimusAlso: AfinitorSelf-administered as a daily dose of 10mg orally | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
Related trials for Advanced Hormone Receptor Positive (HR+) Breast Cancer
Not yet recruitingPhase 1
A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast Cancer
Breast Cancer, Hormone-receptor-positive Breast Cancer
RecruitingPhase 2
Trastuzumab Deruxtecan vs Endocrine Therapy in Low-HER2 HR+ Advanced Breast Cancer
Hormone Receptor(HR)-Positive, Low HER2 Advanced Breast Cancer Patients (HER2 IHC 1+ or 2+ & ISH Negative)
RecruitingObservational study
Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study
Breast Adenocarcinoma, Breast Cancer Stage IV
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing everolimus in people with Advanced Hormone Receptor Positive (HR+) Breast Cancer, run by Novartis Pharmaceuticals.
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 13 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 9 Dec 2021.