Gemcitabine for Breast Cancer

2
Effectiveness
3
Safety
Alabama Oncology, Birmingham, AL
Breast Cancer+3 More
Gemcitabine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether a drug may help treat triple negative breast cancer.

See full description

Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms
  • Triple Negative Breast Neoplasms
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Gemcitabine will improve 1 primary outcome and 3 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Cycle 1 Day 1 (each cycle is 21 days) up to 14 months.

Month 28
Effect on Overall Survival (OS)
Month 14
Myeloprotective Effects
Quality of life/Effects On Chemotherapy-Induced Fatigue
Month 14
Progression Free Survival

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Placebo + gemcitabine + carboplatin
Trilaciclib + gemcitabine + carboplatin
Placebo group

This trial requires 250 total participants across 2 different treatment groups

This trial involves 2 different treatments. Gemcitabine is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Trilaciclib + gemcitabine + carboplatinTrilaciclib (240mg/m2) + gemcitabine (1000 mg/m2) and carboplatin (AUC 2)
Placebo + gemcitabine + carboplatinThe subjects in the placebo arm will follow the same schedule as the trilaciclib arm, but will receive placebo instead of trilaciclib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trilaciclib
FDA approved
Carboplatin
FDA approved
Gemcitabine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: cohort 2: from date of randomization up to 28 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly cohort 2: from date of randomization up to 28 months for reporting.

Closest Location

Alabama Oncology - Birmingham, AL

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:
Documentation of PD-L1 positive status
Treated with a PD-1/PD-L1 inhibitor for a minimum duration of 4 months in the locally advanced unresectable/metastatic setting and as the most recent therapy.
Age >/= 18 years of age with evaluable locally advanced unresectable or metastatic TNBC.
Documentation of triple negative breast cancer (estrogen and progesterone receptor <1% and HER2-negative)
No prior systemic therapy in the locally advanced unresectable/metastatic setting including chemotherapy, targeted therapy, immunotherapy, or investigational agents.
Prior PD-1/PD-L1 inhibitor treatment is not permitted in any setting, including in the neoadjuvant setting.
Time between completion of last treatment with curative intent and first metastatic recurrence must be ≥ 6 months.
Radiation therapy for metastatic disease is permitted. There is no required minimum washout period for radiation therapy. Patients should be recovered from the effects of radiation.
Archival tumor tissue must be available or a fresh biopsy must be obtained, unless approved by the Medical Monitor.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

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?

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Breast cancer treatment is highly dependent on a number of factors, primarily related to the [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) type. There are currently no effective treatments for the majority of cancer types or with the exception of mastectomy type 2 (a mastectomy with breast tissue removal, but with the breast reconstructed by implantation of silicone gel or silicone-filled breast implants), where mastectomy type 1 (a mastectomy with breast tissue removal, with or without reconstructive surgery after mastectomy), is the standard of care. It is important to learn the basics of treatments for breast cancer. Treatment must follow accepted national and international guidelines, as well as individual patient needs.

Unverified Answer

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

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Nearly one in 25 women will be diagnosed with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in her lifetime. Breast cancer is the most frequent cancer and the most common cause of death from cancer among women in this report.

Unverified Answer

What causes breast cancer?

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The evidence that breast and ovarian cancer are closely associated suggests that endocrine disrupting agents may play a role in tumorigenesis and the role of diet and environmental factors in the development of breast cancer. It has also been clearly shown that genetic factors play a role in the risk of developing breast cancer.

Unverified Answer

What are the signs of breast cancer?

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The signs and symptoms of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) can result from secondary causes. All patients with new or unexplained symptoms of a malignant lump, and every patient with a past history of breast disease should be screened for cervical or breast cancer.\n

Unverified Answer

What is breast cancer?

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A patient with Breast cancer usually has an unexplained lump in the breast or nipple or she has a change in the shape, size or colour of the breast. There can be a range of signs and symptoms associated with breast cancer. Breast cancer is often diagnosed during the screening programmes of breast cancer. In 2015, Breast cancer was the cause of 1 in 9 deaths in GB, and in the year after (2011–2) this accounted for 1 in 36.5 of cancer deaths.\n

Unverified Answer

Can breast cancer be cured?

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There are limited data available in the English-language literature to support the idea that most [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s can be cured. More research is warranted. Patients' desires for a cure for their disease are widely discussed in the literature, however, because patients who identify as having cancer may be more concerned about the possibility of cure than about dying, these discussions should be reported with caution.

Unverified Answer

How does gemcitabine work?

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Gemcitabine, in contrast to its clinical use to treat cancers, does not appear to exert the desired effect on normal cells. There is a strong desire for clinical trials to evaluate the activity of gemcitabine in the treatment of cancers, even on normal tissues, as has been done for other chemotherapeutic agents used in cancer therapy

Unverified Answer

What does gemcitabine usually treat?

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We could not identify any patient who actually received gemcitabine for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). This may be because the authors' search for treatments in the article's title was insufficient. Thus, patients do not need to have breast cancer to receive gemcitabine, but patients with this cancer type often are eligible for gemcitabine as part of the treatment. Therefore, it is difficult to tell why the authors chose this particular drug as its own treatment in the first place.

Unverified Answer

Have there been other clinical trials involving gemcitabine?

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On the basis of the findings in this study, it appears as though gemcitabine does not appear to be effective in patients who have previously received neoadjuvant/adjuvant chemotherapy. Results from a recent paper are discussed in terms of possible molecular mechanisms of cytotoxicity, the role of gemcitabine metabolism or uptake, or the possibility of alternative mechanisms of cell death in chemotherapy-treated breast cancer.

Unverified Answer

What is the survival rate for breast cancer?

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Survival for early breast cancer has substantially improved over the past 50 years with the current 5-year survival rate for stage II breast cancer estimated to be 91%. I am not very well but my recurrence did not show in the bone or brain either.

Unverified Answer

Is gemcitabine typically used in combination with any other treatments?

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Gemcitabine combined with some chemotherapy regimens is one of the most commonly used medicines within the NHS. However, when the combination contains only gemcitabine, the cost of treatment increases. Although the cost of gemcitabine treatment of breast cancer using an intravenous infusion is still about £12,000 per cycle, the cost of administration with paclitaxel and docetaxel has risen by nearly £30,000 since the introduction of gemcitabine and pemetrexed-based regimens. The NHS budget must, therefore, be mindful of the need to restrict the number and type of combinations of chemotherapy drugs available, in order to reduce the overall cost of treatment.

Unverified Answer

What are the latest developments in gemcitabine for therapeutic use?

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The study is one of the first investigations into the use of gemcitabine to treat breast cancer. The research findings show positive results and potential role for this compound on the treatment of breast cancer as an effective cytotoxin or chemotherapeutic agent. Although the underlying mechanism of action for gemcitabine is yet to be fully elucidated, further study into their use for the treatment of breast cancer is warranted.

Unverified Answer
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