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Current trials in follow-up

Trial assigning individualised options for treatment (TAILORx trial)

Purpose

To investigate the use of the Oncotype DX assay, a specialised laboratory test to predict breast cancer recurrence in women with early stage hormone receptor positive and node negative breast cancer. The aim of the research is to investigate whether women with an intermediate Oncotype DX breast cancer recurrence score (11-25) benefit from chemotherapy in addition to endocrine treatment.

Scientific Title

A phase III, multicentre, multinational, randomised trial of adjuvant chemotherapy plus hormone treatment versus adjuvant hormone treatment alone for patients with previously resected, axillary node-negative, invasive breast cancer with various levels of risk for recurrence.

Background

Breast cancer treatment usually involves one or more of the following options – surgery, chemotherapy, hormone therapy and radiotherapy.  Traditionally, the choice and combination of treatments depends on factors such as the type, size and aggressiveness of the breast cancer, whether it is hormone (oestrogen and progesterone) receptor positive or not, and whether the cancer has spread to the lymph nodes in the armpit/axilla. Chemotherapy is often recommended for the treatment of early breast cancer to lower the risk of the breast cancer returning. However, doctors now recognise that chemotherapy benefits some early breast cancer patients more than others, and may be unnecessary altogether for certain patients.

The TAILORx trial involves the use of a diagnostic test called the Oncotype DX Breast Cancer Assay. The Oncotype DX Assay measures the levels of a specific set of 21 genes in a breast tumour. Looking at the levels of these genes helps researchers and doctors better estimate a patient’s individual risk of cancer recurrence. The results of this test are entered into a computer which produces a score between 0 – 100, known as a Recurrence Score (RS). A RS of < 10 indicates a low risk breast cancer and chemotherapy isn’t recommended, and a RS of > 26 indicates a high risk breast cancer and chemotherapy is recommended. The TAILORx trial is investigating whether or not women with a RS of 11-25 (intermediate risk) would benefit (or not) from chemotherapy.

Enrolment: Closed

The Suppression of Ovarian Function Trial (SOFT)

Purpose

The SOFT trial is investigating the role of ovarian function suppression and the role of exemestance in premenopausal women.

Scientific Title

IBCSG 24-02/BIG 2-02: SOFT phase III trial evaluating the role of ovarian function suppression and the role of exemestane as adjuvant therapies for premenopausal women with endocrine responsive breast cancer.

Background

Chemotherapy has been shown to lower the risk of recurrence in some premenopausal women (generally women under the age of 50 years) with breast cancer. In addition, standard treatment also includes hormonal therapy to decrease the chance of the cancer reappearing at a later date.

Hormonal therapy has been shown to help prevent breast cancers coming back after surgery if the breast cancer has hormone receptors. Standard hormonal treatment in younger women has consisted of the oestrogen blocking drug tamoxifen which is usually given for five years. Another class of hormonal drugs called aromatase inhibitors, to which the drug exemestane belongs, has shown promising results in postmenopausal women. Aromatase inhibitors do not work well on their own in premenopausal women, as high levels of oestrogens are present, but are effective when ovarian function is suppressed.

Premenopausal women with breast cancer may also benefit from suppression of the ovaries in order to simulate menopause. This ovarian function suppression can be achieved by either radiotherapy to the ovaries, surgical removal of the ovaries, or by drugs known as the GnRH analogues given as a monthly injection. Supressing the ovaries will reduce the production of oestrogen in the body. Adding an aromatase inhibitor will further lower the level of oestrogen. This overall lowering of oestrogen may be beneficial, as oestrogen can cause breast cancer cells to grow.

The SOFT is being done to see if suppressing ovarian function plus giving tamoxifen is better at preventing the return of breast cancer than giving tamoxifen alone in younger  women. It will also look at whether the hormone drug exemestane plus suppression of the ovaries is better than tamoxifen alone, or tamoxifen plus suppression of the ovaries. It is unclear whether any additional benefit is derived from suppression of ovarian function as no trial has addressed this question to date.

Enrolment: Closed

Sentinel Node biopsy versus Axillary Clearance trial Part 2 (SNAC2)

Purpose

SNAC2 aims to determine the long-term safety of sentinel node based management, especially in women with larger or multiple tumours.

Scientific Title

Sentinel Lymph Node Biopsy versus Axillary Clearance In Operable Breast Cancer 2 – (SNAC 2). A multicenter randomised trial of The Royal Australasian College of Surgeons Section of Breast Surgery in collaboration with the National Health and Medical Research Council (NHMRC) Clinical Trials Centre.

Background

When breast cancer spreads it can travel to other parts of the body through the blood and lymph systems. The lymph nodes in the armpit are often the first place where breast cancer spread is detected.  Knowing whether or not these nodes contain cancer is important and used to advise women about prognosis (the risk of recurrence from breast cancer) and additional treatment (for example, endocrine therapy or chemotherapy). Removal of involved nodes may also help prevent local recurrence in the armpit.

Surgical removal and examination by the pathologist is the most reliable way to assess these armpit lymph nodes.  Standard surgery at present (2007 when SNAC2 trial commenced) involves removal of most of the lymph nodes from the lower and upper part of the armpit. This is called axillary clearance or axillary node dissection.  However, this operation is associated with certain risks including infection, pain, shoulder stiffness, upper arm numbness and lymphoedema (arm swelling).  A lesser surgery called sentinel node biopsy which involves removal of the first lymph nodes related to the breast cancer; may provide reliable information on axillary/armpit node status.

The initial Sentinel Node Biopsy versus Axillary Clearance Part 1 (SNAC 1) study, aimed to answer the question: “In women with small breast cancers, does sentinel node biopsy result in reduced side effects from surgery compared to standard axillary clearance? ”Part 2 of this research evaluates the use of sentinel node biopsy in women with larger breast cancers or with more than one cancer in the breast, to answer the very important question; “Does sentinel node biopsy result in increased local recurrence or decreased survival, and if so, for which group of women is this the case, and for whom is axillary clearance really necessary?

Enrolment: Closed

SUPREMO Trial (Selective Use of Postoperative Radiotherapy aftEr MastectOmy

Purpose

To establish the benefits of postoperative radiotherapy to the chest wall in women who have undergone mastectomy and who are at intermediate risk of recurrence. This is in addition to anti-cancer drugs given in the form of chemotherapy or hormonal therapy (or a combination of both).

Scientific Title

BIG 2-04: SUPREMO, an MRC phase III randomised trial to assess the role of adjuvant chest wall irradiation in ‘intermediate risk’ operable breast cancer following mastectomy.

Background

Radiotherapy treats breast cancer using high energy x-rays to destroy cancer cells and the aim of radiotherapy is to reduce the risk of the tumour coming back. In addition, when given in conjunction with anti-cancer drug treatments, it may also improve long-term survival. Radiotherapy is routinely given to women after mastectomy, when they are at “higher” risk of their breast cancer returning (e.g. when the tumour is large or when there is four or more lymph nodes involved by cancer). International controversy continues regarding which “moderate” risk group of women require radiotherapy after mastectomy and this international randomised trial is underway to attempt to further address this issue.

Enrolment: Closed

MonarchE trial

Purpose

To evaluate whether the combination of abemaciclib (an experimental drug) plus standard endocrine therapy improves outcomes in women or men with hormone receptor positive (HR+) & human epidermal receptor 2 negative (HER2 -) high risk breast cancer compared to endocrine therapy alone.

Scientific Title

MonarchE: Protocol I3Y-MC-JPCF A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer.

Background

Breast cancer is the most frequently diagnosed cancer among women and is a major cause of cancer-related deaths worldwide. The most prevalent sub-type of breast cancer is hormone receptor-positive (HR positive), human epidermal growth factor receptor 2-negative (HER2 negative) breast cancer and accounts for 70% of all breast cancers.

Approximately 90% of breast cancer patients are diagnosed at an early stage of their disease. With current standard of care endocrine therapy and chemotherapy, approximately 30% of HR positive breast cancer patients who are initially diagnosed at early stage, experience distant relapse with metastases (spread of the cancer from the primary site to other parts of the body). Thus, there is a critical need to improve the absolute benefit of adjuvant endocrine therapy for HR positive breast cancer patients who are at high risk of disease recurrence.

Abemaciclib is an oral drug which stops the production of proteins in the body called CDK4 and CDK6, which are responsible for promoting cell growth. This mechanism and abemaciclib has been shown to have antitumour activity and significantly reduce tumour growth, including breast cancer.

Enrolment: Closed

This clinical trial is an industry sponsored (Eli Lilly) trial.

Positive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy (POSNOC trial)

Purpose

The POSNOC trial is a clinical research trial available in NZ looking at the armpit treatment provided to women diagnosed with early stage breast cancer and one or two sentinel nodes involved with cancer spread. The trial will help determine if axillary treatment is no longer needed meaning that some women will be able to avoid unnecessary treatment and long term side effects of treatments.

POSNOC is of considerable importance in terms of improving outcomes for women with breast cancer and also in understanding breast biology.

Scientific Title

Protocol RD-5103-001-13: POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy. A randomised controlled trial of axillary treatment in women with early stage breast cancer who have metastases in one or two sentinel nodes or “POSNOC trial”.

Background

The usual treatment following breast cancer surgery is to give chemotherapy or endocrine therapy (hormone therapy), or both. Radiotherapy may also be given to the breast or chest wall. These treatments are called adjuvant therapy.

At the moment, it is also usual for women with cancer spread in 1 or 2  lymph sentinel nodes to have further treatment to their armpit (axilla). This treatment is either an operation to remove extra lymph nodes from the armpit (axillary node clearance), or radiotherapy to the armpit (axillary radiotherapy).  Researchers want to find out whether this further treatment to the armpit is really needed.

Researchers now know that other breast cancer treatments are very good at preventing cancer from coming back. Some research results suggest that the extra armpit treatment after sentinel node biopsy may not change the risk of cancer coming back so the axillary treatment may no longer be needed. However, many experts believe that further evidence is needed to prove whether this is the case.

Enrolment: Closed