A Study of Experimental Medicine Ipatasertib for Early Stage Triple Negative Breast Cancer

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Age: 18 years or older
Gender:
Female
Healthy Volunteers: No
Keywords: triple negative breast cancer, breast cancer, early breast cancer
Type: Drug study, Phase 2
Target:
15 Participants
Investigator:
Description
The purpose of this study is to compare the effects of the experimental drug ipatasertib.

In this study, you will receive:
- ipatasertib plus paclitaxel (a common type of chemotherapy) or
- placebo (an inactive substance that looks like ipatasertib) plus paclitaxel.

Ipatasertib is an experimental drug. This means that health authorities (such as the FDA) have not approved it to treat breast cancer.

Paclitaxel is a drug that is already approved in some countries for the treatment of breast cancer. Paclitaxel will be an investigational drug for this study.

A placebo looks like the study drug but does not contain any drug. Researchers use a placebo to see if the study drug works better or is safer than not taking anything.

Ipatasertib is designed to block the activated form of Akt, a protein that is known to promote the growth of cancer cells. Paclitaxel is a type of chemotherapy that kills or stops the growth of cancer cells. Early studies suggest that the combination of ipatasertib and paclitaxel may improve tumor responses.

Currently, ipatasertib is being tested in patients with:
- triple-negative breast cancer (hormone receptor-negative/HER2- negative breast cancer; hereafter known as TNBC) and
- hormone receptor-positive/HER2-negative breast cancer (hereafter known as HR + /HER2− breast cancer), and
- other types of cancer.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Premenopausal or postmenopausal women
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically documented, Stage Ia to operable Stage IIIa, triple-negative carcinoma of the breast with primary tumor greter than or equal to (>/=) 1.5 centimeters (cm) in largest diameter (cT1-3) by MRI
  • Adequate hematologic and organ function within 14 days before the first study treatment
  • Availability of tumor tissue from formalin-fixed, paraffin-embedded (FFPE) core biopsy of breast primary tumor
  • For female participants of childbearing potential, agreement to use highly effective form(s) of contraception for the duration of the study and for at least 6 months after last dose of study treatment

Exclusion criteria:

  • Known human epidermal growth factor 2 (HER2)-positive, estrogen receptor (ER)-positive, or progesterone receptor (PgR)-positive breast cancer
  • Any prior treatment for the current primary invasive breast cancer
  • Participants with cT4 or cN3 stage breast tumors
  • Metastatic (Stage IV) breast cancer
  • Bilateral invasive breast cancer
  • Multicentric breast cancer
  • Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You take study treatments until your cancer worsens (progresses), until the study treatment becomes intolerable, or until the completion or termination of the study. After your last dose of study drug, the study doctor will ask you to visit the office for a treatment completion visit within 28 days after your last dose of study treatment. If your cancer has not yet worsened by the treatment completion visit, you will return to the clinic for disease follow-up visits every 8–12 weeks until disease progression. You will also be contacted by telephone about every 3 months to determine your long-term health status, to complete a questionnaire about your health, to find out if you are taking any anti-cancer drugs and your associated tumor response.
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Breast Cancer