Current partner codePEPTIDESDE
NCT02476786·Phase 2·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 2

Enrollment

50

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

BEHAVIORAL

FACT-B

The FACT-B (Version 4) is a 37-item measure that contains the four general subscales along with the Breast Cancer-Specific subscale that assesses symptoms/concerns of particular relevance to breast cancer (e.g., body image, arm swelling and tenderness).

DRUG

Goserelin

DRUG

Anastrozole

DRUG

Exemestane

DRUG

Fulvestrant

DRUG

Tamoxifen

OTHER

Archived tissue collection

Timeline

From registration to results.

  1. First posted

    Jun 19, 2015

  2. Study start

    Jan 17, 2017

  3. Primary completion

    Jan 31, 2027

  4. Study completion

    Jul 31, 2032

  5. Results posted

    Not reported

  6. Registry updated

    Jul 27, 2026

Outcomes

What the study measures.

Primary outcomes

Response rate

Time frame · 6 months

* 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 outcomes

Breast cancer-specific survival

Time frame · 6 months

Breast cancer-specific survival

Time frame · 1 year

Breast cancer-specific survival

Time frame · 2 years

Rate of overall survival

Time frame · 5 years

Eligibility

Who can take part.

Minimum age
70 Years
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
No

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Washington University School of Medicine

St Louis, Missouri, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Goserelin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.