Everolimus trIal for Advanced prememopausaL Breast Cancer Patients

NCT02313051 | Unknown Phase 2

• 1 other identifier: CBCSG016
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Everolimus has been approved to be effective when used with exemestane after progression on non-steroidal aromatase inhibitors in postmenopausal women based on the BOLERO-2 clinical trial. However, the superiority of addition of everolimus to endocrine therapy hasn't been established in the premenopausal women. This is a phase 2, multicentre clinical trial to evaluate the role of everolimus in the first-line endocrine treatment of premenopausal MBC patients after progression on tamoxifen.

Conditions

Metastatic Breast Cancer

Keywords

metastatic breast cancer, everolimus

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  the time from randomization to the time of disease progression or relapse or death

  6 months after last patient was evaluated

Secondary Outcomes (4)

• Overall survival

  1 year after the last patient was followed-up

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  during screening and treatment, withing 28 days after last medication

• Clinical benefit rate

  at the time of tumor assessment of last patient

• Duration of clinical benefit

  6 months after last patient was evaluated

Study Arms (2)

Everolimus arm

EXPERIMENTAL

Everolimus+letrozole

Drug: Everolimus; Drug: Goserelin; Drug: Letrozole

Controll arm

ACTIVE COMPARATOR

letrozole alone, and when progress, followed by everolimus

Drug: Goserelin; Drug: Letrozole

Interventions

Everolimus DRUG

mTOR inhibitor

Also known as: Certican, Rad001

Everolimus arm

Goserelin DRUG

Also known as: Zoladex

Controll arm; Everolimus arm

Letrozole DRUG

Also known as: Femara

Controll arm; Everolimus arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative surgery.
• Histological confirmation of estrogen and/or progesterone-receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2 -) breast cancer.
• ER/PR positive: nuclear reaction \> 1%, HER2 negative: HER2; IHC 0,1+ or FISH/CISH (-) in case of IHC 2+
• Patients who:
• received Tamoxifen for at least 6 months during adjuvant treatment and recurred during or within 24 months after the end of adjuvant treatment completion,
• progressed during tamoxifen treatment for advanced disease.
• Pre-menopausal status was defined as either :
• The patient has a history of regular menstrual periods within 12 weeks prior to study enrollment
• The patient has FSH and E2 levels with in pre-menopausal range based on local laboratory assessments measured (i.e, FSH ≤ 40 mIU/mL and E2 ≥10 pg/mL)within 12 weeks prior to study enrollment.
• ECOG performance status of 0,1, or 2
• At least one measurable lesion or mainly lytic bone lesions in the absence of measurable disease(RECIST1.1)
• Adequate bone marrow, hepatic, and renal function
• Adequate bone marrow and coagulation function as shown by:
• Absolute neutrophil count (ANC) ≥ 1.5 109/L;Platelets\>100 x109/L;Hemoglobin (Hgb) \> 9.0g/dLINR \< 2
• Adequate liver function as shown by:

You may not qualify if:

• Patients who have received endocrine treatment other than Tamoxifen for adjuvant or metastatic/locally advanced breast cancer.
• Patients who have received goserelin at adjuvant setting
• Patients who received more than one line of chemotherapy for metastatic or locally advanced breast cancer
• Previous treatment with mTOR inhibitors.
• Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.
• Symptomatic brain or other CNS metastases
• Patients receiving chronic treatment with immunosuppressive agents.
• Any severe and/or uncontrolled medical conditions, eg. currently active infection
• Pregnant or lactating
• Patients unwilling to or unable to comply with the protocol.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Related Publications (1)

• Fan Y, Sun T, Shao Z, Zhang Q, Ouyang Q, Tong Z, Wang S, Luo Y, Teng Y, Wang X, Wang S, Liu Q, Feng J, Shen K, Song Y, Wang J, Ma F, Li Q, Zhang P, Xu B. Effectiveness of Adding Everolimus to the First-line Treatment of Advanced Breast Cancer in Premenopausal Women Who Experienced Disease Progression While Receiving Selective Estrogen Receptor Modulators: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):e213428. doi: 10.1001/jamaoncol.2021.3428. Epub 2021 Oct 21.

  PMID: 34436536 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Everolimus; Goserelin; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bing he Xu, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Fan, MD

CONTACT

861087788114; fanyingfy@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of medical oncology

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 9, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: December 9, 2014

Record last verified: 2014-11

Locations

CN (1)