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OpenTrials
Completed

NCT Number: NCT01265654

Reasons for Changing HOrmonal Therapy of Advanced Breast Cancer

Breast cancer is the leading type of cancer in women. Although big advance in diagnostics and treatment of early and breast cancer has been made in recent years breast cancer still has a significant mortality rate. A number of treatment modalities exist for postmenopausal women with advanced breast cancer. The treatment modality is chosen based on patient and tumour characteristics. Hormonal treatment is preferred and recommended in women with hormone sensitive breast cancer (ESMO, CECOG and NCCN guidelines). Tumor markers are an established method of monitoring systemic therapies in various cancers. Tumor markers CA 15-3 and CEA are used in clinical practice to monitor treatment efficacy of metastatic breast cancer. Blood levels of tumor markers are widely used to assess response/progression to treatment and guide therapy change. Treatment efficacy is assessed by imaging methods in clinical studies. Change of therapy in clinical study is usually done when progression based on RECIST criteria is found. Hormonal treatment has slower onset of effect compared with chemotherapy that can last several weeks. Also when a new therapy is started spurious early rises may occur. Therefore rising levels of tumor markers during the first weeks of new hormonal therapy are not necessarily sign of progression and should not be the only guidance for treatment change. Evidence of treatment efficacy form clinical studies and treatment change is based on imaging techniques.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Benesov U Prahy, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with at least two finished lines of hormonal treatment for advanced breast cancer Tumor markers (CEA. CA15-3) values available at the time of onset and discontinuation of therapy Imaging methods results available at the time of onset and discontinuation of therapy

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Reasons for change of hormonal therapy (biochemical progression, objective progression, symptomatic progression, safety reasons, other)

    Time frame: Every 3 months

Secondary outcomes

  1. Changes in values of tumor markers (CEA, CA 15.3)

    Time frame: Every 3 months.

  2. Time to progression

    Time frame: Every 3 months

  3. Type of hormonal treatment

    Time frame: Every 3 months.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: HOT ABC

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 23, 2010
Registry last updated
Nov 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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