CLINICAL TRIAL

Treatment for Breast Cancer

1 Prior Treatment
Grade II
Metastatic
Recurrent
Waitlist Available · 18+ · Female · Tucson, AZ

This study is evaluating whether a new drug called lapatinib is as good as trastuzumab in keeping metastatic breast cancer from growing.

See full description

About the trial for Breast Cancer

Eligible Conditions
Breast Neoplasms · Breast Cancer

Treatment Groups

This trial involves 2 different treatments. Treatment 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 3 and have had some early promising results.

Control Group 1
trastuzumab
BIOLOGICAL
+
paclitaxel
DRUG
+
docetaxel
DRUG
Control Group 2
paclitaxel
DRUG
+
lapatinib ditosylate
DRUG
+
docetaxel
DRUG

Eligibility

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Breast Cancer or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The hormone receptor status for this tumor is not specified. show original
We have a formalin-fixed paraffin-embedded tumor specimen available for research purposes. show original
is the only indication for palliative chemotherapy Palliative chemotherapy is used to relieve the symptoms of cancer, and is only recommended for people who have metastatic (stage IV) cancer at the time of diagnosis or after they have had radiation or chemotherapy treatments to try to cure the cancer. show original
30% or more of the tumor cells show a strong, positive signal for 3+. show original
In ≤ 30% of invasive tumor cells, there is overexpression of 2+ or 3+ of HER2/neu by immunohistochemistry (IHC) and gene amplification is demonstrated by fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH). show original
Patients with a HER2/neu gene amplification (FISH/CISH ratio of ≥ 2.2, or ≥ 6 HER2/neu gene copies per nucleus) are eligible. show original
is the most common type of breast cancer show original
There are no signs of cancer spreading to the central nervous system (including the leptomeninges). show original
Menopausal status not specified
A person with an ECOG performance status of 0-2 is generally considered to be an outpatient. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 4 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 11 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Not available at this time.

Economic Evaluation, Including Health Utilities, as Measured by the EQ-5D Questionnaire, and Healthcare Utilization
NOT AVAILABLE AT THIS TIME
NOT AVAILABLE AT THIS TIME
Effects of Changes in Biomarkers on Clinical Outcomes
NOT AVAILABLE AT THIS TIME
NOT AVAILABLE AT THIS TIME
Quality of Life as Measured by the EORTC QLQ-C30 Global Score From Baseline to 12 Weeks
12 WEEKS
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The global score ranges from 0-100, with higher values representing a better quality of life. At 12 weeks: Group mean difference between arms
12 WEEKS
Clinical Benefit Response Rate (HER2/Neu+))
24 WEEKS
Best overall response of CR, PR, or stable disease at end of week 24.
24 WEEKS
Clinical Benefit Response Rate (ITT)
24 WEEKS
Best overall response of CR, PR or stable disease at end of week 24.
24 WEEKS
Time to CNS Metastases at the Time of First Progression
FROM RANDOMIZATION TO CNS METASTASES AT TIME OF FIRST PROGRESSION, ASSESSED UP TO 39 MONTHS.
FROM RANDOMIZATION TO CNS METASTASES AT TIME OF FIRST PROGRESSION, ASSESSED UP TO 39 MONTHS.
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Patient Q & A Section

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

What is breast cancer?

Breast cancer is the leading cause of cancer-related deaths and is a major health issue for women throughout the Western world. It typically arises in older women and is related to risk factors such as hormone replacement therapy and breast cancer gene mutations. Breast cancer is one in the family of cancers, and its screening is considered a high priority by many governments.

Anonymous Patient Answer

How many people get breast cancer a year in the United States?

About 7.1 million women become newly diagnosed with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) each year, accounting for 6.7% of all breast cancer cases. This is the third highest incidence rate among cancer types, after cervical and endometrial cancers. Women in the black race and Hispanic race and ethnicity have a higher incidence rate of breast cancer, but this incidence rate is still lower than that of women in the white race. As with other cancer types, the age of diagnosis for breast cancer increases and the likelihood of dying of the disease also increases with age. There is no significant difference between men and women in lifetime risk.

Anonymous Patient Answer

What are the signs of breast cancer?

It is not only the patient who can help to identify certain signs, but also the doctor of the patient. The following signs have been found to be significant for diagnosis of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer): palpable masses in the breast, pain in the shoulder, and a palpable mass in the arm. These symptoms can be identified using a checklist which is presented in the appendix.

Anonymous Patient Answer

What causes breast cancer?

Breast cancer has a high rate of hereditary genes. On average women have one BRCA1/2 mutation in 4 to 10% of cases and up to 50% of women may have one mutation. Women with BRCA1/2 have an up to 4-fold higher risk of breast cancer. Women who have BRCA2 mutation have an even higher breast cancer risk of 10-15 times greater than does the general population. In addition to these high risk women, those with multiple relatives with breast cancer have higher breast cancer risk. Women with breast cancer have higher levels of estrogens in the body in response to hormones, such as androgens, growth hormones and thyroid hormones.

Anonymous Patient Answer

Can breast cancer be cured?

It has become increasingly clear that while the potential to cure is certainly present, the practicality of this potential is still in question. A meta-analysis has shown a low cure rate (5.3%) in patients receiving conservative adjuvant treatment in which patients receive the intent on eliminating the disease at the time of first diagnosis. The benefit of treatment has a narrow margin of safety and depends on the natural history of the breast cancer, the extent of disease and the individual. It also depends on the quality of the treatment administered (if any) and the duration of treatment. For all these reasons it is inappropriate to assume that a cure is possible.

Anonymous Patient Answer

What are common treatments for breast cancer?

Most women with breast cancer are treated with surgery, radiation therapy, hormone therapy, or a combination of these. Common treatments include mastectomy, paclitaxel infusion, trastuzumab, and alkylating chemotherapy.

Anonymous Patient Answer

Is treatment safe for people?

People with very poor health status including people with advanced age, people with poor general health and children and infants might find it difficult to tolerate treatment. People who are not well informed regarding the treatment should be fully counseled.

Anonymous Patient Answer

What is the survival rate for breast cancer?

Data from a recent study shows that breast cancer survivors living 1 year after treatment are 2-3 times more likely to die than the general population, the cause being mainly cardiovascular related deaths. Women can then have a good survivorship to reach the overall age-standardized survival figure at the population rate at all age stages.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

There could be a more effective and acceptable new treatment option for postmenopausal women who have to rely on a number of different types of anti-estrogens.

Anonymous Patient Answer

What is the latest research for breast cancer?

“New therapies for breast cancer will likely continue to emerge. Current research has produced several treatments that prolong survival when breast cancer metastasizes to distant organs. Researchers are also working to develop vaccines or a vaccine cocktail that can mount an immunological reaction in patients with breast cancer and may prevent distant metastasis.” While no breast cancer vaccine is in production at this time, and treatment requires many patients undergo immunotherapy and hormone replacement.

Anonymous Patient Answer

Who should consider clinical trials for breast cancer?

In summary, women who are informed about clinical trials need to be willing and able to support this decision. The type of information and options that should be introduced to explain what will happen in the trial are dependent on women's perceptions.

Anonymous Patient Answer

What is the average age someone gets breast cancer?

There are an average of 10,800 new cases of breast cancer annually in the United States and it is much more common in women in their late 20s and 30s. Overall breast cancer happens more often in women younger than 60. Every year about 6,550 women will be diagnosed with breast cancer. There will be 8,230 deaths due to breast cancer in the year 2020.

Anonymous Patient Answer
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