DCIS Clinical Trials 2023

What Are DCIS Clinical Trials?

Ductal carcinoma in situ (DCIS) is a proliferation of malignant cells in the ductal structures of the mammary gland without crossing the basal lamina. It accounts for 10% of all breast cancers and 25 to 30% of breast carcinomas detected radiographically.

This particular form of cancer, often called "pre-cancer" or "false cancer," and even non-cancer as a marker of breast cancer risk greatly fuels overdiagnosis.

Its incidence has increased over the past decades due to the introduction of organized breast cancer screening. Over the past few decades, women diagnosed with DCIS essentially followed the introduction of population-based breast cancer screening.

Most DCIS cases are discovered during mammographic screening because the lesion is not palpable and patients are asymptomatic. The lesions found on mammography are microcalcifications in 75% of cases. Mammography has a detection sensitivity of about 85% for DCIS and can be supplemented with magnetic resonance imaging (MRI).

The excessive treatment burdens on women's well-being have already been recognized. Women with DCIS are labeled as "cancer patients," with attendant anxiety, even though lesions do not progress to invasive breast cancer in most DCIS cases. The inability to distinguish harmless lesions from invasive ones often ends up inflicting excessive treatment on many DCIS patients, affecting their quality of life.

Until now, the risk factors for revision surgery in DCIS have been little studied. Therefore, researchers from leading academic institutes worldwide have been studying this condition, and several clinical trials are underway to deepen its understanding and discover therapeutic techniques.

Why Is DCIS Being Studied Through Clinical Trials?

Despite being a pre-or even non-invasive lesion and although the natural course of this intraductal process is unknown, DCIS is still considered the non-obligatory early form of (stage 0) breast cancer. The fear of being unable to distinguish harmless lesions from potentially invasive forms leads to the proposal of excessive treatment of this condition in many patients.

Therefore the classic management is to treat all DCIS lesions with a treatment that includes either mastectomy or breast-conserving surgery supplemented by radiotherapy.

Research has also discovered that most women with DCIS have little knowledge about their condition and have inaccurate perceptions of the risk of disease progression, which is often associated with significant psychological distress. Given all these elements, it is considered that the current management of DCIS consists of excessive treatment.

The research shows recovery rates ranging from 18 to 67%. Therefore, more and more DCIS clinical trials are underway to determine effective diagnostic methods, the rate of recovery of invaded edges in DCIS, and to define possible preoperative risk factors f for unhealthy edges.

What Are The Types of Treatments Available For DCIS?

The reference treatment for DCIS is surgery and consists of either a partial mastectomy (MP) associated with adjuvant irradiation or a total mastectomy (TM). The radical nature of the surgical procedure is established according to clinical data (breast volume, size, age) and radiological examinations.

Conservative treatment is retained for classically unifocal lesions with a size of less than 4–5 cm. However, this partial surgery exposes the risk of excision margins invaded or borderline in anatomopathology.

The state of the excision margins is an independent and significant risk factor for recurrence found in many clinical trials.

What Are Some Recent Breakthrough Clinical Trials For DCIS?

Below are some of the most notable DCIS clinical trials:

2023: Efficacy of Tamoxifen (4-hydroxytamoxifen) in Controlling DCIS - This is an ongoing trial studying the effectiveness of Tamoxifen in controlling DCIS when given through the breast skin. One of the causes of breast cancer cell growth is estrogen. This trial aims to assess the efficacy of tamoxifen citrate or afimoxifene as a primary hormone therapy in treating DCIS by blocking estrogen usage by the tumor cells.

2020: Efficacy of Letrozole in Women with Postmenopausal Ductal Carcinoma In Situ - Hwang et al. conducted this trial to evaluate the effectiveness of a short-term course of letrozole as the primary endocrine therapy and an alternative to surgery in treating DCIS, which had been understudied. The purpose was to evaluate whether letrozole results in measurable changes in estrogen receptors (ER) in women with ER-positive DCIS. The results showed significant biomarker and imaging changes in postmenopausal ER-positive DCIS patients using letrozole. This study paved the way for further trials on studying endocrine therapy alternative treatment to surgery in some DCIS cases.

Who Are Some of The Key Opinion Leaders on DCIS Clinical Trials Research?

Shelley Hwang, MD, MPH

Dr. Hwang is a Surgical Oncologist at the Duke Cancer Institute. Her areas of expertise include DCIS, Breast Cancer Risk Reduction, Mastectomy, and Breast-Conserving Surgery. Her research interests have always been in DCIS, among others, and she has conducted multiple trials to determine effective treatment methods alternative to surgery to control DCIS..

Seema A. Khan, MD

Dr. Khan is a surgical oncologist and a professor of Surgery at Northwestern University. She is a leader of the Cancer Prevention program at the Robert H. Lurie Comprehensive Cancer Center and has been a researcher in cancer-focused research. She has conducted multiple trials on breast cancer prevention and breast cancer and DCIS risk biomarkers.