Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Breast Diseases

Skin Diseases

Quality of Life

* Women with a screen-detected breast cancer after attending BreastScreen Norway
* Women who have never attended BreastScreen Norway despite of several invitation, and who are diagnosed with symtomatic breast cancer.

Both groups of women will receive the questionnaire.

* Women with a screen-detected breast cancer after attending BreastScreen Norway
* Women with interval breast cancer after attending BreastScreen Norway
* Women with symptomatic breast cancer, who have never been screened in BreastScreen Norway
* Women free from breast cancer

* Women with a screen-detected breast cancer after attending BreastScreen Norway
* Women with interval breast cancer after attending BreastScreen Norway
* Women with symptomatic breast cancer, who have never been screened in BreastScreen Norway

Solveig Hofvind, PhD

The objective of this project is to generate evidence about quality of life related to side effects of treatment of women with screen-detected versus symptomatic breast cancer. The project will investigate the impact of detection mode (by screening or by symptoms) versus tumor characteristics as a predictor of quality of life among breast cancer survivors. The burden of long-term effects, measured as quality of life at specific points after diagnosis, will be compared between these groups. The results will also be compared with a control group of women, who have attended screening, but never been diagnosed with breast cancer.

The project will include a retrospective information which will be collected by using a self-administered questionnaire about the treatment women received and their quality of life at certain time points after a breast cancer diagnosis. Women aged 50-69 years at the time of diagnosis are the target group of BreastScreen Norway and also for this project.

The women will be identified from the Cancer Registry databases. The questionnaire will be based on EQ-5D-5L and will be developed in close collaboration with breast cancer survivors who have personally experienced the long-term effects of breast cancer treatment, whether resulting from screen-detected or symptomatic breast cancer.

The questionnaire will cover topics related to demographics, treatment, and information required to estimate health related quality of life (HRQoL) and Quality-Adjusted Life Years (QALY). Information about detection mode and disease stage at diagnosis will be extracted from the Cancer Registry.

Study I - a review of the literature in a paper describing and analyzing the current evidence on quality of life among women diagnosed with breast cancer and treated for this disease, with a focus on disease stage at diagnosis. Due to substantial changes in treatment during the last decades, only studies reporting on women who have received treatment in 1995 or later will be included. Solely studies written in English will be included.

For studies II, III and IV, data collected from the self-administered questionnaire will be used. In addition, information about screening history and tumor characteristics will be obtained from the Cancer Registry of Norway.

In Study II, quality of life will be compared between 1000 women treated for screen-detected and 1000 women treated for symptomatic breast cancer. The main hypothesis is that women with screen-detected breast cancer have a higher quality of life than women diagnosed with symptomatic breast cancer.

Study III will be a continuation of Study II, where quality of life among women with screen-detected breast cancer, interval breast cancer, breast cancer diagnosed outside the screening program and women without any diagnosis of breast cancer will be analyzed. The main hypothesis is that women with no history of breast cancer and those with a screen-detected breast cancer have a higher quality of life than those diagnosed with an interval breast cancer or breast cancer detected outside the screening program.

The aim of Study IV is to investigate the impact of detection mode versus tumor characteristics as the main predictor of long-term quality of life among women diagnosed and treated for breast cancer among the two groups of women treated for breast cancer (diagnosed with sceen-detected breast cancer, diagnosed with interval breast cancer, and diagnosed with symptomatic breast cancer).

Long-term Effects of Breast Cancer Treatment

Long-term Effects Following Treatment of Women With Screen-detected Versus Symptomatic Breast Cancer

QALY is defined as one year of life in perfect health and calculated by estimating the years of life remaining for a woman following a particular treatment or intervention and weighting each year with her corresponding health related quality of life score

Extrastiftelsen

Cancer Registry of Norway

All Drugs and Chemicals

Antineoplastic Agents

Herbal and Botanical

Estrogens

Anastrozole

Aromatase Inhibitors

Phytoestrogens

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Flax

Flaxseed 25 mg per day and 1 placebo pill per day

25 mg flaxseed per day and 1 mg anastrozole pill per day

flaxseed

Placebo

Tracey L O'Connor, MD

The proposed study plans to examine the effect of flaxseed consumption, a phytoestrogen rich food, compared to aromatase inhibitors as a complementary approach to treating estrogen receptor positive breast cancer, as well as the effect of combined flaxseed and aromatase inhibitor therapy on breast cancer treatment. Because of the increasing use of both complementary and alternative approaches to treatment, and the use of aromatase inhibitors in the treatment of breast cancer, the proposed study has potential to provide important clinical information about the effect of foods high in phytoestrogens on a common endocrine therapy used in breast cancer.

Although the 10 year survival rate for women with early stage breast cancer is very good, distant recurrence is still a serious concern, especially for estrogen receptor positive women. Consequently, breast cancer survivors are interested in therapies that might improve their recurrence free survival (RFS). Used in postmenopausal women, aromatase inhibitors (AI) block the peripheral conversion of androgens to estrogen, effectively lowering the estradiol available to promote breast tumor proliferation. However, use of AIs is associated with hot flashes, joint pain, bone loss, and an increase in cardiac events. Furthermore, many breast tumors eventually develop resistance to hormonal treatments. Complementary and alternative medicines (CAMs) are widely used by cancer survivors in an attempt to reduce disease recurrence with fewer side effects and potential health benefits, and use is particularly prevalent among breast cancer survivors. Flaxseed (FS) is a commonly available food often consumed as a dietary supplement and is the richest food source of lignans, a phytoestrogen. In experimental models, flaxseed consumption has been shown to exhibit a number of activities that suggest a potential benefit of flaxseed in the adjuvant setting. However, the majority of human studies investigating the biologic effects of flaxseed have involved healthy women. There is a paucity of clinical data regarding the efficacy and safety of use of flaxseed among women with breast cancer, especially among those receiving AIs. Because the phytoestrogens in flaxseed can influence many of the same biologic pathways affected by hormonal agents, diet-drug interactions are possible. Additionally, it is possible flaxseed could act through growth and signaling pathways, modifying the development of endocrine resistance. Potential synergistic or antagonistic effects between flaxseed and antiestrogens are of particular interest given the increasing use of AIs to treat postmenopausal women with hormone responsive disease. We propose to conduct a pilot 2x2 factorial randomized intervention study between tumor biopsy and resection, in postmenopausal women diagnosed with ER positive breast cancer, to assess the effects of flaxseed and AI on a number of steroid hormone and tumor-related characteristics associated with long-term survival, and to investigate the potential interaction between flaxseed and AI on tumor expression of Ki-67, caspase, ERα, ERβ, PgR, HER2, IGF1, IGFIR. The pre-surgical setting offers a unique opportunity to rapidly obtain information on intervention related effects on growth factor and signaling pathways related to tumor characteristics in a short time period without the interference of other treatments. We hypothesize that both flaxseed and AI interventions will independently favorably affect growth factor and signaling pathway protein expression resulting in reduced tumor proliferation and increased apoptosis. We further hypothesize that these improvements will be reflected in improved recurrence scores as estimated by the Mammostrat antibody panel (Applied Genomics Incorporated). The proposed study will provide important clinical data for future dietary intervention studies involving phytoestrogen lignans from flaxseed.

Flaxseed, Aromatase Inhibitors and Breast Tumor Characteristics

Flaxseed vs. Aromatase Inhibitors: Breast Tumor Characteristics and Prognosis

Mean percentage of cells expressing estrogen receptor (ER-beta)

Mean percentage of cells expressing human epidermal growth factor receptor 2 (Her2)

National Center for Complementary and Integrative Health (NCCIH)

AstraZeneca

Roswell Park Cancer Institute

25 mg flaxseed per day and 1 mg anastrozole pill per day

Anastrozole: 1 mg per day

flaxseed: 25 g per day ground

Arm A - Flaxseed & Active Anastrazole

Flaxseed 25 mg per day and 1 placebo pill per day

flaxseed: 25 g per day ground

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Long-term Effects of Breast Cancer Treatment	NCT03877029	Breast Cancer		50 Years - 69 Years	Cancer Registry of Norway
Flaxseed, Aromatase Inhibitors and Breast Tumor Characteristics	NCT00612560	Breast Cancer	Anastrozole flaxseed Placebo	18 Years - 85 Years	Roswell Park Cancer Institute
Long-term Effects of Breast Cancer Treatment	NCT03877029	Breast Cancer		50 Years - 69 Years	Cancer Registry of Norway
Long-term Effects of Breast Cancer Treatment	NCT03877029	Breast Cancer		50 Years - 69 Years	Cancer Registry of Norway

Spots Global Cancer Trial Database for tumor characteristics