Breast Cancer Research Trust NZ, gaining knowledge and saving lives

Current trials in follow-up

Lymph Node Grafting for Breast Cancer Related Lymphoedema

Scientific Title

Lymph node grafting for upper limb lymphoedema following breast cancer treatment

Purpose

This trial will compare the novel surgical technique of lymph node grafting in addition to standard lymphoedema therapy against standard lymphoedema therapy alone. Clinical trial participants will be those with residual stage one to two breast-cancer related lymphoedema despite initial treatment with standard lymphoedema therapy. Participants are randomised to either surgery plus standard therapy or standard therapy alone.

The surgical procedure involves lymph node grafting from groin to upper limb. This technique is carried out by trained Plastic and Breast Surgeons and involves an incision in the groin with removal of two lymph nodes under general anaesthetic. Lymph nodes are then grafted into the subcutaneous tissue of the elbow and wrist of the affected limb. Surgeons have a minimum of five years experience and the surgery is carried out in one surgical procedure and takes approximately 60 minutes.

Background

Upper limb lymphoedema is a common and often distressing side effect of breast cancer treatment. Reconstructive lymphatic microsurgery may be considered if conservative treatment fails but is highly specialized and expensive.

Enrolment: Closed

This clinical trial has been made possible by a grant from the Cancer Society of New Zealand, support for surgery from Alison Surgical Centre and Braemar Hospital. Funds raised from the Fine Homes Tour 2017 and the Waikato Sunrise Rotary have also enabled this research. Mr Winston McEwan (Plastic Surgeon and Principal Researcher) and Mr Ian Campbell (Breast Surgeon and Co-Researcher) also donate their time.

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

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.