CLINICAL TRIAL

Paclitaxel for Breast Cancer

Metastatic
Stage II
Waitlist Available · 18+ · All Sexes · Bronx, NY

This study is evaluating whether chemotherapy before surgery and tissue sample collection is safe for patients with stage IIA-IIIC breast cancer.

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About the trial for Breast Cancer

Eligible Conditions
Stage IIIA Breast Cancer · Stage IIA Breast Cancer · Carcinoma Breast Stage IV · Breast Cancer, Stage IIIB · Breast Neoplasms · Stage IIB Breast Cancer · Breast Cancer Stage IIIc

Treatment Groups

This trial involves 3 different treatments. Paclitaxel is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Cyclophosphamide
DRUG
+
Paclitaxel
DRUG
+
Cytology Specimen Collection Procedure
OTHER
+
Laboratory Biomarker Analysis
OTHER
+
Doxorubicin Hydrochloride
DRUG
Experimental Group 2
Cyclophosphamide
DRUG
+
Paclitaxel
DRUG
+
Cytology Specimen Collection Procedure
OTHER
+
Trastuzumab
BIOLOGICAL
+
Laboratory Biomarker Analysis
OTHER
+
Doxorubicin Hydrochloride
DRUG
Experimental Group 3
Cyclophosphamide
DRUG
+
Paclitaxel
DRUG
+
Cytology Specimen Collection Procedure
OTHER
+
Laboratory Biomarker Analysis
OTHER
+
Doxorubicin Hydrochloride
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Paclitaxel
FDA approved
Trastuzumab
FDA approved
Doxorubicin
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People with adenocarcinoma of the breast that meets certain criteria can participate in neoadjuvant therapy studies show original
No chemotherapy, irradiation, or definitive surgical treatment (eg, mastectomy or lumpectomy or axillary dissection) for this cancer; patients who have had a prior sentinel lymph node biopsy for this cancer are eligible. show original
The study participants must be able to understand and sign a written informed consent document, and be willing to provide blood samples and have research biopsies performed before and after therapy. show original
for early-stage breast cancer The following must be known before starting systemic therapy for early-stage breast cancer: the estrogen receptor (ER), progesterone receptor (PR), and HER2/neu status of the primary tumor and/or regional lymph node. show original
Patients must have had a bilateral diagnostic mammogram within 6 months of registration show original
with paclitaxel Patients who are suspected to have axillary lymph node involvement must have a biopsy or aspiration cytology prior to starting therapy with paclitaxel. show original
It is strongly encouraged that all patients have metallic clips placed in the tumor prior to neoadjuvant therapy in order to facilitate evaluation for microscopic disease at the time of surgery; placement of clips is particularly encouraged for patients being considered for breast conserving surgery
Patients who have taken tamoxifen or another SERM in the past are eligible to participate in this study as long as they have stopped taking the drug at least one week before enrolling. show original
The patient is a good candidate for preoperative chemotherapy and surgery as judged by the doctors treating them. 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: Baseline to 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline to 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to 6 months.
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 Paclitaxel will improve 1 primary outcome and 1 secondary outcome in patients with Breast Cancer. Measurement will happen over the course of Baseline to 8 weeks (2 courses).

Changes in quantitative biomarker levels in patients with chemotherapy-responsive and -resistant tumors, including senescence, cell death, TMEM, mena, and 67LR
BASELINE TO 8 WEEKS (2 COURSES)
Paired T-test or Wilcoxon signed-rank test will be performed. Two-sample t-test will be performed to compare biomarker between the two groups. If the data are not normally distributed, a suitable data transformation such as the log or rank transformation will be applied. Logistic regression models will also be fit to the data with treatment sensitive/resistance category as the outcome and baseline as well as pre-post change in biomarker level as the main predictor variable to obtain estimates of odds ratios unadjusted and adjusted for potential confounders including patients characteristics.
BASELINE TO 8 WEEKS (2 COURSES)
Changes in senescence and secondary biomarkers, including TMEM, mena, and 67LR
BASELINE TO 6 MONTHS
Descriptive statistics by treatment group will be presented. The two-sampled t-test will be performed. Appropriate transformation may be used to improved normality of the outcome variable.
BASELINE TO 6 MONTHS

Who is running the study

Principal Investigator
J. D. A. M.
Jesus D. Anampa Mesias, Principal Investigator
Albert Einstein College of Medicine

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 are common treatments for breast cancer?

Most women with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) will receive treatments including surgery, chemotherapy, and/or hormonal therapy. A small percentage of breast cancers will be cured with some type of radiation therapy, chemotherapy, or immunotherapy. Women with a small percentage of ER positive cancers will also receive hormone therapy. The optimal treatment remains debatable.

Anonymous Patient Answer

What causes breast cancer?

Many factors, including genetics, environmental exposures and occupational exposures, play an important role in the development of breast cancer. Knowledge of these factors can help in the prevention and treatment of breast cancer, although further research is needed to understand more fully any causal relationship.

Anonymous Patient Answer

What is breast cancer?

Breast cancer is an incredibly complex disease with many variables. We discuss the various subtypes and the causes of different subtypes. Breast cancer forms in the skin (dermis), is in the lobules of the breast (lobules) and infiltrates the breasts and elsewhere in the body. We discuss the various subtypes including invasive, ductal, invasive/metastatic, metastatic and other very rare cancers. The different subtypes are distinguished by the type of cells involved and how the cancer develops. We discuss ways that genetics, estrogen and sex may be risk factors for cancers including breast cancer. We also discuss the role of diet, lifestyle, environmental factors, medications and age in breast cancer risk.

Anonymous Patient Answer

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

Cancer incidence rates are much higher among women, but the age-adjusted rates have not appreciably changed compared with the period 1981–1985. The most salient difference is the increasing rate of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in white subgroups of women, especially those in their 60s or younger. The lack of a significant decrease in age-adjusted cancer rates in all women is consistent with most cancer incidence studies but contrasts with the trend towards increasing breast cancer rates observed among white women.

Anonymous Patient Answer

What are the signs of breast cancer?

Some early indications of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include the lump in the breast, a large lump in the breast when compared to breast size, painless nipple discharge and a family history. Other signs of breast cancer include pain in the breast, nipple pain, a lump in the breast and nipple discharge.

Anonymous Patient Answer

Can breast cancer be cured?

There is no evidence that tumorigenesis can be completely reversed in any human cancer. However, in a number of cases where tumorigenesis was completely reversed, remission and control of disease were observed. In the past, remission was used in a very narrow and outdated sense to refer to a remission that is complete and lasting, i.e. that there is no recurrence. However, the word remission and the word cure are now used in a very different meaning. Complete remission, remission lasting for many months or even years, is no guarantee for the ultimate outcome of the cancer or of the patient. In most cases, the recurrence of the cancer is very difficult to detect, and the chances to cure patients are very low.

Anonymous Patient Answer

Is paclitaxel typically used in combination with any other treatments?

Taxanes are typically added to neoadjuvant chemotherapy; combined with other taxanes; in part or full to other antitumor regimens; and as monotherapy. Additional randomized trials are urgently needed to identify effective combinations of paclitaxel with anticancer agents and other biologically active agents.

Anonymous Patient Answer

What is the primary cause of breast cancer?

Lifestyle modification is the major cause of breast cancer. Obesity and obesity-related factors also contribute to the incidence of breast cancer, whereas cigarette smoking and alcohol use have no convincing impact.

Anonymous Patient Answer

What is the survival rate for breast cancer?

The majority of women with early breast cancer can expect 5 years of survival as the long-term disease and overall quality of life does not seem to be compromised by age and overall health.

Anonymous Patient Answer

Is paclitaxel safe for people?

The authors concluded that adjunctive paclitaxel is safe in the treatment of breast cancer. They reported no clinically significant increase in toxicity with paclitaxel versus capecitabine. Paclitaxel does not require special precautions to avoid inter-patient variation in drug-eluting stent implantation or coronary artery bypass graft surgery in the treatment of breast cancer.

Anonymous Patient Answer

Does breast cancer run in families?

Identifying a hereditary predisposition to breast cancer is difficult, but the incidence of BRCA mutations is very high (5 to 10%). BRCA1,2 and 3 mutations have an earlier age of onset. BRCA2 and 3 cases of breast cancer (63 and 50% respectively) are related to Ashkenazi Jewish ancestry. To be useful genetic counselling should be offered as part of a routine genetic counselling to individuals presenting with breast cancer and/or at high-risk population.

Anonymous Patient Answer

What is paclitaxel?

Paclitaxel's antitumor activity in vivo has been demonstrated in mice. Paclitaxel shows some degree of activity in human breast tumors grown SC in athymic mice, but no antitumor activity in human breast tumors grown in nude mice. This supports the concept that paclitaxel works differently in different mouse models.

Anonymous Patient Answer
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