Clinical Trial: NCT02476786 - My Cancer Genome

NCT02476786

Description:

Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. A new standard of care needs to be defined for elderly women with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. The investigators hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast cancer and low Ki67 scores.

Related Conditions:

Breast Carcinoma

Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02476786

Trial Eligibility

Document

Title

Brief Title: Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score
Official Title: Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score

Clinical Trial IDs

ORG STUDY ID: 201611010
NCT ID: NCT02476786

Conditions

Breast Cancer
Cancer of Breast
Breast Neoplasms
Cancer of the Breast

Interventions

Drug	Synonyms	Arms
Goserelin	Goserelin acetate, Zoladex	Endocrine therapy alone
Anastrozole	Arimidex®	Endocrine therapy alone
Exemestane	Aromasin®	Endocrine therapy alone
Fulvestrant	Faslodex®	Endocrine therapy alone
Tamoxifen	Nolvadex®	Endocrine therapy alone

Purpose

Trial Arms

Name	Type	Description	Interventions
Endocrine therapy alone	Experimental	Neoadjuvant endocrine therapy will be given at the discretion of the treating physician as directed by the package insert and could include the following: goserelin, anastrozole, letrozole, exemestane, fulvestrant, or tamoxifen Frequency of office visits will be decided by the treating physician but must occur no less frequently than every 3 to 6 months for tumor assessment After 6 months and after 12 months, patients will be assessed; patients who progress will have standard care recommended , and at any point a patient can opt to receive standard care even if she has not progressed on neoadjuvant endocrine therapy Information on quality of life will be collected at baseline, Year 1, and Year 2 by the FACT-B questionnaire Archival tissue will be collected and sent to Genomic Health for analysis using the Oncotype DX assay. The Recurrence Score predicts chemotherapy benefit and indicates the 10-year risk of recurrence (will not be used to determine treatment)	Goserelin Anastrozole Exemestane Fulvestrant Tamoxifen

Eligibility Criteria

        Inclusion Criteria:

          -  Newly diagnosed histologically or cytologically confirmed operable invasive breast
             cancer defined as cT1 or T2, N0-1, and M0.

          -  Disease must be ER+ and HER2-.

          -  Ki67 score/proliferative index ≤ 30% or low to intermediate mitotic index

          -  Measurable disease defined as lesions that can be accurately measured in at least one
             dimension (longest diameter to be recorded) by ultrasound or mammogram.

          -  70 years of age or older.

          -  ECOG performance status ≤ 3

          -  Able to understand and willing to sign an IRB approved written informed consent
             document (or that of legally authorized representative, if applicable).

        Exclusion Criteria:

          -  Prior surgery for this cancer

          -  A history of other malignancy ≤ 5 years previous which would preclude endocrine
             treatment of their cancer.

          -  Currently receiving any other investigational agents.

          -  A history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to any of the agents used in the study.

          -  Uncontrolled intercurrent illness as determined by their treating physician which
             would limit compliance with study requirements.

          -  Known HIV-positivity on combination antiretroviral therapy because of the potential
             for pharmacokinetic interactions with endocrine therapies. Appropriate studies will be
             undertaken in patients receiving combination antiretroviral therapy when indicated.

Maximum Eligible Age:	N/A
Minimum Eligible Age:	70 Years
Eligible Gender:	Female
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Response rate
Time Frame:	6 months
Safety Issue:
Description:	Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]. In each RECIST response category Oncotype DX scores will be summarized with mean, standard deviation, minimum, 1st, 2nd (median) and 3rd quartiles, and maximum values. OncotypeDx scores range from 0 to 100, with scores <18 indicating low risk.

Secondary Outcome Measures

Measure:	Breast cancer-specific survival
Time Frame:	6 months
Safety Issue:
Description:

Measure:	Breast cancer-specific survival
Time Frame:	1 year
Safety Issue:
Description:

Measure:	Breast cancer-specific survival
Time Frame:	2 years
Safety Issue:
Description:

Measure:	Rate of overall survival
Time Frame:	5 years
Safety Issue:
Description:

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Washington University School of Medicine

Last Updated

February 10, 2021

Clinical Trials /

Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score