Treatment for Triple Negative Breast Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Harris Health System - Smith Clinic, Houston, TX
Triple Negative Breast Neoplasms+12 More
Eligibility
18+
All Sexes
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Study Summary

This study is evaluating whether a tumor's response to chemotherapy predicts how much of the tumor will remain after surgery.

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Eligible Conditions

  • Triple Negative Breast Neoplasms
  • Breast Cancer, Stage II
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))
  • HER2-positive Breast Cancer
  • Breast Cancer, Stage III
  • Hormone Receptor-positive Breast Cancer
  • Breast Cancer
  • Estrogen Receptor-positive Breast Cancer
  • Neoplasms, Breast
  • Malignant Neoplasm of Female Breast
  • Invasive Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Triple Negative Breast Neoplasms

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 2 secondary outcomes, and 1 other outcome in patients with Triple Negative Breast Neoplasms. Measurement will happen over the course of Baseline and at surgery (after 20 weeks).

20 weeks
Change in circulating tumor DNA (ctDNA) levels from baseline to surgery
Pathologic Complete Response Rate in each Breast Cancer Subtype
Predictive value of clinical response following 1 cycle of chemotherapy to predict pathologic complete response
Week 20
Change in Clinical Tumor Measurement vs. Pathologic Response

Trial Safety

Safety Progress

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

Other trials for Triple Negative Breast Neoplasms

Trial Design

4 Treatment Groups

Triple Negative Breast Cancer (for tumors > 5 cm)
1 of 4
Triple Negative Breast Cancer (for tumors < 5 cm)
1 of 4
Hormone Receptor Positive Breast Cancer
1 of 4
HER2-Positive Breast Cancer
1 of 4
Active Control

This trial requires 185 total participants across 4 different treatment groups

This trial involves 4 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 2 and have already been tested with other people.

Triple Negative Breast Cancer (for tumors > 5 cm)Paclitaxel IV plus Carboplatin IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total)
Triple Negative Breast Cancer (for tumors < 5 cm)Paclitaxel IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total)
Hormone Receptor Positive Breast CancerPaclitaxel IV plus Carboplatin IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total)
HER2-Positive Breast CancerPaclitaxel IV plus Trastuzumab IV plus Pertuzumab IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV administered (4 cycles total)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 20 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 20 weeks for reporting.

Who is running the study

Principal Investigator
M. R.
Prof. Mothaffar Rimawi, Professor
Baylor Breast Care Center

Closest Location

Harris Health System - Smith Clinic - Houston, TX

Eligibility Criteria

This trial is for patients born any sex 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:
Must be at least 18 years old, and legally able to provide informed consent. Both men and women are eligible.
Participants must have histologically confirmed, invasive breast cancer. Tumor may be triple negative (as defined by ASCO-CAP guidelines), HER2-positive (as defined by ASCO-CAP guidelines), or high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines). High risk is defined as a tumor that meets at least two of the following criteria: 1) histologic grade 3; 2) patient age less than 50 years; 3) Estrogen Receptor (ER) < 6/ or 4) ki-67 ≥ 30%.
Tumors must be at least 2 cm by clinical exam (palpation or ultrasound).
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Participants must have a left ventricular ejection fraction ≥ the institutional lower limit of normal, as assessed by echocardiogram or Multigated Acquisition (MUGA )scan.
Absolute Neutrophil Count (ANC) ≥ 1200/mm3
Platelets ≥ 100,000/mm3
Hemoglobin ≥ 10 g/dL
Total bilirubin ≤ institutional upper limit of normal (ULN), unless the patient has Gilbert's disease or similar syndrome
Alkaline phosphatase (ALP) ≤ 2.5 x institutional ULN

Patient Q&A Section

What are common treatments for breast cancer?

"Breast cancer is a complex disease and there are many different treatments available, but they all can be classified into six main categories of treatment: surgery, radiation therapy, chemotherapy, hormonal therapy, targeted therapy and immunotherapy.\n\nSurgery often consists of removing the lump through a surgical procedure called lumpectomy.\n\nRadiation therapy uses X-rays and sometimes also gamma rays to treat the cancer cells.\n\nChemotherapy or chemo drugs are used to kill cancer cells. There are many different kinds of chemotherapy and they are used either alone or together with other treatment. Types of chemotherapy include:\n- Alkylating agents (e.g." - Anonymous Online Contributor

Unverified Answer

What is treatment?

"There is no single 'right' treatment for any patient. Each individual has different needs and expectations. It is important to remember that treatment needs to address all aspects of the patient’s health. Treatments need to address the patient’s medical history, family history, social support network, and her physical abilities. Treatments also need to take into account the psychological, emotional, and spiritual needs of the patient. Breast cancer treatment guidelines are evolving and changing over time. The available data do not allow us to definitively state which treatment is ‘best’ for any specific patient. We only know about what treatments work best for certain patients with certain types of breast cancer." - Anonymous Online Contributor

Unverified Answer

Has treatment proven to be more effective than a placebo?

"With all of these studies, we cannot answer this question definitively. However, based on previous studies, there appears to be no difference between treatments and placebos when tested against two clinic trials. More studies need to be conducted to determine the efficacy of any of these alternative treatments." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with breast cancer?

"Treatment improved QOL among women with breast cancer. Women reported better QOL when they received multimodal therapy compared with those receiving chemotherapy alone. Higher education and higher income appear to be associated with better QOL. Health care providers should provide information about benefits and risks of adjuvant treatment." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for breast cancer?

"A large proportion of women who were considered for clinical trial enrollment did not complete requests to enroll in clinical trials. Many patients received inconsistent treatment due to lack of information regarding clinical trial status. Recent findings suggest that clinical trial notification and enrollment may improve patient outcomes." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing breast cancer?

"No significant relationship was observed between the risk of developing BC and the total number of pregnancies, parity, breastfeeding and age at first pregnancy. However, women who had used hormonal contraception were more likely to develop BC." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"Treatment works by removing the cancer cells from the body when there are no more viable cancer cells left. As the cancer evolves, it becomes either non-malignant or malignant again. When the cancer exists only in the blood, it will get removed without any treatment. However, if the cancer remains malignant, then treatment must be given to remove all the cancer cells from the body. There are many different types of cancer treatments. But most of them focus on removing the cancer cells from the body and that's why they are called “removal” treatments." - Anonymous Online Contributor

Unverified Answer

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

"Women with no known risk factors account for more than 95% of new cases of breast cancer annually. About 5% of women who develop breast cancer will be diagnosed before age 45 years; most of these will receive adjuvant therapy. No significant differences were observed in the adjusted incidence rates of breast cancer among black women, white women, and Hispanic women over the period 1979-1993." - Anonymous Online Contributor

Unverified Answer

How quickly does breast cancer spread?

"We found no evidence of significant differences between women who developed metastases within five years versus those who did not develop metastases within five years following diagnosis; however, our results were limited by small numbers in each group. To confirm our results with larger numbers of patients, additional studies are needed." - Anonymous Online Contributor

Unverified Answer

Can breast cancer be cured?

"Although surgery has always been considered the only curative option for early breast cancer, we believe that the results reported here have led to a shift towards the use of systemic treatment in addition to surgery. Systemic therapy may improve the disease-free survival but does not appear to guarantee cure. Further studies are required to develop the best combination of therapies for use in patients with advanced breast cancer." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets breast cancer?

"Breast cancer treatment outcomes are improving; however, younger women do not fare as well compared to those older than 50 years old. Breast cancer remains the leading cause of cancer-related deaths among women aged 20-39 years." - 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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