Research Article - Annals of Clinical Trials and Vaccines Research (2023) Volume 13, Issue 1

Neoadjuvant Clinical Trials Update for Triple-Negative Breast Cancer

Xinjin Guo*

Department of Medicine, Cancer Hospital of Zhengzhou University, China

*Corresponding Author:
Xinjin Guo
Department of Medicine, Cancer Hospital of Zhengzhou University, China
Tel: +867856592331

Received: 01-Feb-2023, Manuscript No. ACTVR-23-88009; Editor assigned: 04-Feb-2023, PreQC No. ACTVR-23-88009(PQ); Reviewed: 18- Feb-2023, QC No. ACTVR-23-88009; Revised: 21-Feb-2023, Manuscript No. ACTVR-23-88009(R); Published: 28-Feb-2023; DOI: 10.37532/ ACTVR.2023.13(1).14-16


Despite the high rates of treatment response, aggressive triple-negative breast cancer (TNBC) has a terrible prognosis. This situation emphasizes the necessity to create new medicines and/or treatment plans to lower the mortality linked to TNBC. In comparison to the usual adjuvant paradigm, the neoadjuvant environment offers a model for quick evaluation of therapy efficacy with lower patient accruals and over shorter time frames. The term “pathologic complete response” already exists in this context as a crystal-clear surrogate endpoint for enhanced survival. The current findings from finished and ongoing neoadjuvant clinical studies for TNBC are reviewed here. Another crucial research method for identifying chemotherapy resistance mechanisms and fresh therapeutic targets is tissue analysis in the neoadjuvant setting. In this article, we examine data from completed and continuing neoadjuvant clinical studies in patients with TNBC and talk about the challenges researchers and physicians encounter when using neoadjuvant chemotherapy.


Pathology • Breast cancer • Clinical trials •Neoadjuvant • Adjuvant • Chemotherapy • Therapeutic drugs


Triple-negative breast cancer (TNBC) is a unique type of breast cancer that develops quickly, exhibits malignant phonotypes, and has a high rate of recurrence and metastasis in the long term following radical mastectomy, ultimately leading to a bad outcome? Neoadjuvant chemotherapy (NAC), according to current clinical research, is a successful treatment for those with locally advanced breast cancer. NAC has significant negative effects on cancer patients, yet it can successfully shrink tumours to boost the success rate of surgical resection and breast-conserving surgery. Masturbation sheep bud, raw sun ginseng, Atractylodes macrocephala, tortoise plate, entire nail, privet seed, tangerine peel, and other ingredients make up Zhengyuan capsules. It targets the pathophysiology of cancer and functions tonify qi, energise the kidney, and disperse blood stasis. There aren’t many reports on Zhengyuan capsule with neoadjuvant chemotherapy in China right now. In order to treat TNBC, this study set out to investigate the clinical impact of Zhengyuan capsule in combination with neoadjuvant chemotherapy [1].

Histologically, invasive carcinoma of the breast that lacks staining for the HER2/neu, progesterone receptor, or oestrogen receptor is known as triple-negative breast cancer (TNBC). This trait is present in approximately 15-20% of breast cancer cases. TNBC has a high proliferative rate, an early recurrence rate, and a low rate of survival. Although commonly used targeted medicines like trastuzumab and endocrine therapy like tamoxifen and aromatase inhibitors have been successful in lowering breast cancer mortality, this aggressive disease is unresponsive to them. TNBC is more common in younger women and women of African heritage. Patients with stage IV TNBC have few and frequently poor therapeutic therapy options [2].

Materials and Method

We chose 120 TNBC patients who underwent radical mastectomy at our hospital between September 2014 and September 2017. 120 patients with TNBC were randomly split into two groups: a control group (n = 60) and an observation group (n = 60) using the computerized random number grouping method. The two groups’ overall clinical statistics were compared. Here are the numbers. The observation group’s age was an average of (55.50 8.63) years old, with 51 cases of invasive ductal carcinoma and 9 cases of invasive lobular carcinoma, compared to the control group’s age of (53.85 10.35) years, which included 54 cases of invasive ductal carcinoma and 6 cases of invasive lobular carcinoma. The Ethics Committee gave its clearance to this project (approval no. 2013- 187-20). The signed informed consent was given by each patient [3].

Over the past few decades, there has been a dramatic rise in the use of neoadjuvant chemotherapy for patients with locally advanced breast cancer. Patients with breast cancer that was unremarkable or just marginally respectable were the first to get neoadjuvant treatment. Initial research findings revealed significant rates of tumour response and regression. Additional clinical trials were conducted with the main goal of figuring out whether breast conserving surgery might be provided to patients who would typically need mastectomy after neoadjuvant chemotherapy [4].

In the preoperative or postoperative Adriamycin and cyclophosphamide treatment groups, 1,523 women with operable breast cancer were randomly assigned in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-18 research. According to this study, breast conserving rates increased with neoadjuvant chemotherapy (67.8% vs. 59.8%). Despite the fact that there was no difference in overall survival (OS) between the groups receiving neoadjuvant and adjuvant therapy, patients who underwent neoadjuvant treatment and whose tumours achieved a pathologic complete response (pCR) at surgery (defined as no histologic evidence of invasive tumour cells in the breast) had higher diseasefree survival (DFS) and overall survival (OS) rates than those who had residual disease. Other neoadjuvant investigations have also found a correlation between pCR and survival results. As a result, pCR is currently regarded as a crucial endpoint in clinical trials evaluating the effectiveness of neoadjuvant chemotherapy [5].

Similar to how different subtypes of breast cancer have different gene expression patterns and consequent clinical outcomes; each subtype has a different response to neoadjuvant chemotherapy. For instance, the pCR rate for patients with hormone receptor (HR)-positive tumours was 8% following chemotherapy that was either anthracyclineor anthracycline/taxane-based. Contrarily, while having a worse overall prognosis than patients with HR-positive cancer, the pCR percentage for TNBC patients receiving comparable therapy was discovered to be 25%. Data from numerous illustrious clinical researches support these phenomena, known as the “triple negative paradox,” although the cause is mainly unknown [6].


Breast cancer that lacks the human epidermal growth factor receptor 2 (HER-2) as well as the oestrogen receptor (ER), progesterone receptor (PR), and progesterone receptor (PR) is referred to as triple-negative breast cancer (TNBC). TNBC has been on the rise recently, and its prevalence in breast cancer is also progressively rising. In contrast to other breast cancers, young women are more likely to get triple-negative breast cancer, and the tumours are larger as well. TNBC develops quite quickly, and its outcomes and morbidity within 5 years are, respectively, poor and extremely high [7].

The pathophysiology of TNBC is unclear as of this writing. Radical mastectomy is frequently used to treat TNBC due to the lack of a specific treatment. Additionally, after surgery, the patients are vulnerable to recurrence and metastasis, and the prognosis is often poor. Neoadjuvant chemotherapy reportedly has suppressive effects on the triple-negative breast cancer lesions following surgery. Although radical mastectomy has toxic side effects for patients, postoperative treatment is ineffective in preventing long-term recurrence and metastasis in individuals with TNBC [8].

The role, timing, and ideal patient population of platinum’s in the preoperative therapy of TNBC will continue to be defined by ongoing investigations. For instance, patients are being actively enrolled in the Cancer and leukemia Group B (CALGB) 40603 clinical trial, which is using the usual neoadjuvant anthracycline/taxane therapy without carboplatin (NCT00861705). Breast core biopsies taken prior to treatment are necessary at study admission. Future usage of platinum drugs in this scenario will be influenced by the clinical results and correlative endpoints of this study [9].

Neoadjuvant chemotherapy is currently the norm for some TNBC patients, notably those with clinical stages 2B or 3, while it is plausible to argue that any patient whose biopsy reveals invasive disease would be qualified. This strategy encourages breast conservation and offers a crucial foundation for translational research. For evaluating the clinical outcome over the long term in TNBC, pCR is a suitable substitute. The substantial percentage of TNBC patients who do not achieve pCR poses a treatment challenge even though pCR rates to conventional chemotherapy are greater in TNBC than in HR positive breast cancer. Therefore, additional research is essential to pinpoint predictors of resistant populations in order to develop mechanism-based therapies in the neoadjuvant setting that will increase pCR rates and long-term outcomes. The utilization of axillary surgery and the function of postoperative regional radiation (nodes and chest wall in the context of mastectomy) in patients with pCR are two other topics that continue to be the subject of controversy and debate [10].


Although TNBC has a generally dismal prognosis, those who get neoadjuvant chemotherapy had higher response rates and improved breast conservation rates. In this situation, pCR is a suitable endpoint for better long-term outcome prediction. However, approximately 20–40% of patients with the existing therapeutic approaches reach this target. Thus, given the variety of innovative targeted therapies that are now being tested, we advise that patients who come with operable TNBC be encouraged to take part in neoadjuvant clinical trials.

The neoadjuvant context of care offers a perfect model for assessing the effectiveness of new targeted treatments for TNBC. In comparison to conventional adjuvant trials, this strategy enables a smaller patient accrual, quicker turnaround times for data, and routine tissue collection for correlative research. Neoadjuvant trials enable a quicker assessment of cuttingedge TNBC treatments. Additionally, primary tumour core biopsies can be taken both before and during treatment to examine the status of specific biomarkers and determine whether these innovative medicines are inhibiting the predicted targets. For instance, it has been demonstrated that the proliferation-related biomarker Ki- 67 can be used as a helpful proxy for response during or after neoadjuvant endocrine therapy.

Conflict of Interest





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