Core Biopsy for Breast Carcinoma In Situ

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Northwestern University, Chicago, IL
Breast Carcinoma In Situ+8 More
Core Biopsy - Procedure
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This study is evaluating whether a gel which is applied to the skin may help prevent breast cancer from returning in women who have had radiation therapy.

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Eligible Conditions

  • Breast Carcinoma In Situ
  • Ductal Breast Carcinoma In Situ
  • Invasive Breast Carcinoma
  • Cancer Survivors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Carcinoma In Situ

Study Objectives

This trial is evaluating whether Core Biopsy will improve 3 primary outcomes and 2 secondary outcomes in patients with Breast Carcinoma In Situ. Measurement will happen over the course of Up to 35 days post-treatment.

Day 35
Determinants of inter-individual variation in afimoxifene drug concentrations in unradiated breast tissue related to skin histology, blood and lymph vessel density
Determinants of inter-individual variation in afimoxifene drug concentrations in unradiated breast tissue related to the expression of xenobiotic transporters and enzymes
Differences between radiated and non-radiated skin and breast tissue that contribute to differences in permeation
Effect of breast radiotherapy on drug concentrations resulting from transdermal delivery of afimoxifene (4-OHT)
Day 35
Determinants of inter-individual variation in afimoxifene drug concentrations in unradiated breast tissue related to skin features

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Breast Carcinoma In Situ

Trial Design

1 Treatment Group

Treatment (afimoxifene)
1 of 1
Experimental Treatment

This trial requires 120 total participants across 1 different treatment group

This trial involves a single treatment. Core Biopsy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (afimoxifene)Patients apply afimoxifene gel topically QD to both breasts for 4 weeks and then undergo core needle biopsies of both breasts.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Core Biopsy
2013
N/A
~130

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 35 days pot-treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 35 days pot-treatment for reporting.

Closest Location

Northwestern University - Chicago, IL

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months).
Females of child-bearing potential (FOCBP) and male partners of female participants must agree to use TWO effective forms of birth control (abstinence is not an allowed method) prior to study entry and for the duration of study participation, and for two months following the last dose of study medications. Effective birth control methods are: copper IUD (intrauterine device), diaphragm/cervical cap/shield, spermicide, contraceptive sponge, condoms. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
FOCBP must have a negative urine pregnancy test within 7 days prior to registration on study.
Patients must have received prior unilateral breast radiotherapy (RT) for ductal breast carcinoma in situ (DCIS) or invasive cancer (>= 12 weeks after the end of RT), and have an intact unradiated (non-RT) breast.
Note: The upper limit for interval since RT will be 5 years, since oral endocrine therapy (OET) for DCIS is usually administered during the 5 years that follow the end of RT.
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%).
No history of coagulopathy, or daily use of aspirin/nonsteroidal antiinflammatory drugs (NSAIDs).
A prior history of malignancy is allowed, as long as the patient is considered to have ?no evaluable disease? and cancer treatment has been completed.
Has not undergone a hysterectomy or bilateral oophorectomy
Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of the study drug use.

Patient Q&A Section

Can carcinoma, mammary ductal be cured?

"After surgery, carcinoma, mammary ductal cancer may progress in the vast majority of patients, with more than half experiencing further disease. These patients need new and intense treatment." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, mammary ductal?

"The data are discussed in terms of the cancer stem cell hypothesis, and the evidence given supporting this theory to explain the common occurrence of multiple carcinomas in cases of breast cancer." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma, mammary ductal?

"Signs of breast tumors are the changes in the tumor and the skin, as well as some signs of systemic disorders. More detailed knowledge and signs from the whole body, especially the skin, may help the physician diagnose the type of tumor." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, mammary ductal?

"This rare tumour is caused by the precancerous changes of a benign tumour, and is often treated with breast-saving surgery. Although the exact cause of carcinoma, mammary ductal carcinoma is not well understood, many factors may be involved in the development of this tumour. There is no single'single' risk factor (genetic, hormonal, environmental, etc). The development of the carcinoma, mammary ductal tumours is a chronic, but not constant, progression over time. Most cases of carcinoma, mammary ductal are diagnosed at an early stage, when there is a very good chance of cure following surgery and radiotherapy." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, mammary ductal?

"Adenocarcinoma of the breast is treated most often through surgery through a mastectomy or through an alternate option, such as the lumpectomy with negative margins. On the contrary, the majority of women diagnosed with ductal carcinoma report a history of ductal carcinoma in situ (DCIS), with less than 1 percent opting for lumpectomy and less than 40 percent opting for mastectomy if they are diagnosed once the lesion has progressed into invasive carcinoma. All cases of DCIS are treated, whether mastectomies or lumpectomies with an excision margin of negative margins are used." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma, mammary ductal a year in the United States?

"Based on U.S. data, an estimated 2.4 million women are diagnosed annually, an increase of about 4.3% from 2003. Estimates based on death certificate data suggest a total of 18 million women in the U.S. suffer from breast cancer. Over 5.5 million women die from breast cancer each year." - Anonymous Online Contributor

Unverified Answer

Has core biopsy proven to be more effective than a placebo?

"A core biopsy may be effective in patients with a breast mass who were assessed by ultrasound to have a solid mass which could not be palpated." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma, mammary ductal spread?

"Pregnancy and, to a lesser extent, family history represent two significant prognostic factors for survival of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) patients. These factors are also associated with a rapid development of carcinoma in situ and invasive carcinoma. Carcinoma in situ at the time of diagnosis is an excellent prognostic factor, but for many patients a diagnosis of carcinoma in situ and invasive carcinoma in such patients cannot be made earlier. Thus, it is important to identify additional factors that could prompt earlier cancer staging in selected patients." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma, mammary ductal?

"Survival rate for carcinoma with invasive ductal carcinoma is low, as shown in the following. The survival rates for mammary ductal carcinoma should be kept at a high level in order to increase life expectancy of patients." - Anonymous Online Contributor

Unverified Answer

Is core biopsy typically used in combination with any other treatments?

"The use of core biopsy in conjunction with other treatments has improved the diagnostic rate. Core biopsy can provide information necessary for tailored treatment. In addition, core biopsy can be used as an alternative to the open surgical method for treatment of DCIS. Core biopsy should be used as a first-line method of diagnosis when all the criteria are fulfilled: palpable mass with ultrasound-defined lesion, negative margins at excision, and negativity of any hormone receptor status." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma, mammary ductal?

"In a recent study, findings of this population-based study support a referral pathway for clinical trials of MBC patients (and for the first time, breast cancer patients) that includes a thorough patient assessment to determine clinical eligibility for a trial. This pathway will provide a comprehensive care for patients, including an appropriate discussion of their treatment options and, especially, the opportunity of clinical trial participation in the decision-making process." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in core biopsy for therapeutic use?

"Based on these developments, in our opinion, a large amount of high quality, and high cost material can be safely obtained in cases that are not eligible for a biopsy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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