Advertisement

Topics

Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer

2014-08-27 03:59:00 | BioPortfolio

Summary

RATIONALE: Surgery to remove axillary lymph nodes may be an effective treatment for women with breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of therapy with or without axillary lymph node dissection following quadrantectomy in treating older women with stage I breast cancer that is estrogen receptor positive.

Description

OBJECTIVES:

- Compare the efficacy of quadrantectomy with or without axillary lymph node dissection, followed by tamoxifen in terms of local and distant relapse rates and overall survival of patients with stage I, invasive breast cancer.

- Determine the relationship between biological variables, such as hormone receptor status, cell proliferation, and DNA ploidy, and the clinical outcome of the disease in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo quadrantectomy with dissection of level I and II axillary lymph nodes.

- Arm II: Patients undergo quadrantectomy without axillary lymph node dissection. Patients on both arms receive tamoxifen daily for 5 years.

Patients are followed every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 642 patients will be accrued for this study within 3 years.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

tamoxifen citrate, conventional surgery

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan)
Italy
20133

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:00-0400

Clinical Trials [6499 Associated Clinical Trials listed on BioPortfolio]

Tamoxifen Citrate in Treating Premenopausal Women With Estrogen Receptor-Positive Breast Cancer

This randomized clinical trial studies tamoxifen citrate in treating premenopausal women with estrogen receptor (ER)-positive breast cancer. Estrogen can cause the growth of breast cancer ...

Tamoxifen Citrate in Patients With Breast Cancer

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Studyin...

Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors

Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells This phase IIb tri...

Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant or tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. ...

Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage III or Stage IV Breast Cancer

This randomized phase III trial studies tamoxifen citrate or letrozole together with bevacizumab to see how well it works compared with tamoxifen citrate or letrozole alone in treating wom...

PubMed Articles [26536 Associated PubMed Articles listed on BioPortfolio]

Oestrogen receptor-regulated glutathione S-transferase mu 3 expression attenuates hydrogen peroxide-induced cytotoxicity, which confers tamoxifen resistance on breast cancer cells.

Glutathione S-transferase mu 3 (GSTM3) is an enzyme involving in the detoxification of electrophilic compounds by conjugation with glutathione. Higher GSTM3 mRNA levels were reported in patients with ...

Cost-effectiveness of monitoring endoxifen levels in breast cancer patients adjuvantly treated with tamoxifen.

Breast cancer is the most common malignancy in women worldwide. Recurrence rates in breast cancer are considered to be dependent on the serum concentration of endoxifen, the active metabolite of tamox...

CYP2D6 genotype and endoxifen plasma concentration do not predict hot flash severity during tamoxifen therapy.

Tamoxifen is frequently prescribed to prevent breast cancer recurrence. Tamoxifen is a prodrug and requires bioactivation by CYP2D6. Tamoxifen use is often limited by adverse effects including severe ...

Downregulation of lncRNA GAS5 confers tamoxifen resistance by activating miR-222 in breast cancer.

Long noncoding RNAs (lncRNAs) work as oncogenes or tumor suppressors that play important roles in tumorigenesis and chemotherapeutic drug resistance. This study investigates the role of lncRNA growth ...

"Relationship Between Tamoxifen And The Absorption Of Subfascial Autologous Fat Grafts".

In the lipofilling procedures used in breast reconstruction, there is an unpredictability in the rate of reabsorption of the grafted fat. The objective of this study was to analyze the effect of Tamox...

Medical and Biotech [MESH] Definitions

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.

More From BioPortfolio on "Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Breast Cancer
Track and monitor developments in breast cancer research and commercial development.  Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...


Searches Linking to this Trial