CLINICAL TRIAL

ZN-c5 for Breast Cancer

Locally Advanced
Waitlist Available · 18+ · All Sexes · Florham Park, NJ

This study is evaluating whether a combination of two drugs may help treat breast cancer.

See full description

About the trial for Breast Cancer

Eligible Conditions
Breast Neoplasms · Breast Cancer

Treatment Groups

This trial involves 2 different treatments. ZN-c5 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 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Abemaciclib
DRUG
ZN-c5
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved
ZN-c5
2020
Completed Phase 1
~20

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:
is a condition that occurs when a person's body does not produce enough of the human epidermal growth factor receptor 2 protein show original
This is a measure of how well the tumor responds to treatment. show original
Age ≥ 18 years of age
Age ≥ 60 years;
and at least one year of symptoms The person has gone through menopause if they are younger than 60 years old, they have not had a period for at least 12 consecutive months, their serum estradiol and follicle-stimulating hormone (FSH) levels are within the laboratory's reference range for postmenopausal females, and they have experienced at least one year of symptoms. show original
Documented bilateral oophorectomy;
The patient must start receiving a gonadotrophin-releasing hormone agonist at least 4 weeks before the first dose of study medication. show original
A cancer of the breast that is advanced and has been confirmed by a doctor by looking at a sample of the tissue under a microscope. show original
The term "estrogen receptor positive disease" refers to a type of cancer that is sensitive to the effects of estrogen. show original
View All
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
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Through study completion, anticipated to be 21 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Through study completion, anticipated to be 21 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Through study completion, anticipated to be 21 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 ZN-c5 will improve 1 primary outcome and 1 secondary outcome in patients with Breast Cancer. Measurement will happen over the course of Through study completion, anticipated to be 21 months.

Determine tumor responses to combination treatment
THROUGH STUDY COMPLETION, ANTICIPATED TO BE 21 MONTHS
Measured by radiographic responses as defined by revised Response Evaluation Criteria in Solid Tumor (RECIST) v1.1.
THROUGH STUDY COMPLETION, ANTICIPATED TO BE 21 MONTHS
Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib
THROUGH STUDY COMPLETION, ANTICIPATED TO BE 21 MONTHS
Measured by the number of treatment-emergent adverse events and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
THROUGH STUDY COMPLETION, ANTICIPATED TO BE 21 MONTHS

Patient Q & A Section

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

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

Every year more than 1.4 million Americans are diagnosed with breast cancer. This makes up 17.9% of women. The disparity between women and men will only deepen unless there is a change in diagnosis rate.

Anonymous Patient Answer

What causes breast cancer?

It is still difficult to predict the exact cause of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), although a group of women will develop it after a family member has had it. However, the risk increases with the number of relatives with breast cancer diagnosed. It may be that the breasts are more prone to breast cancer if they have been exposed in early childhood to drugs, or radiation. There is evidence that some forms of childhood breast cancer are caused by a virus (Human papilloma virus), which means the risk is related to breast cancer being caused by a virus being a possibility, but this is still a research area.

Anonymous Patient Answer

What is breast cancer?

Breast cancer (MECS) is the most common type of cancer among women in the United States. It is an abnormal cell mass that forms on the tissue of the breast. Most breast cancers can be effectively managed through surgery, chemotherapy, or radiation therapy. Breast cancer affects one and a half million women a year.

Anonymous Patient Answer

Can breast cancer be cured?

Although surgery, radiation therapy, and chemotherapy may be effective in temporarily reducing symptoms, they have no significant effect on the overall survival of people affected by breast carcinoma.

Anonymous Patient Answer

What are common treatments for breast cancer?

Preventive mastectomy is an ongoing clinical procedure. The data obtained in this study indicate that a significant number of women treated at the Breast Unit have delayed diagnosis. They might have been treated outside the unit and had not benefited from the timely and effective mammograms and treatment. The need for mammography screening in women in private practice was high. The data obtained in this study need to be investigated.

Anonymous Patient Answer

What are the signs of breast cancer?

Many signs are consistent with BC, with varying severity and distribution. Common signs are discussed and listed together with their diagnostic yield. These signs can help clinicians determine if further diagnostic work-up is necessary based on the patient's risk factors.

Anonymous Patient Answer

How quickly does breast cancer spread?

It should be understood that it takes time for the disease to spread with or without some treatments. But even if the tumor is in the breast and spreads, it will also not spread to all surrounding areas of the breast and will not spread to the rest of the body at all. This is the only sure way to avoid metastatic cancer that spreads throughout the body after surgery. This is why so many people recover very quickly and fully after surgery without any treatments, because the tumor has not been able to spread to all the lymph nodes of the breast. If untreated, the disease can still spread, but will not move to distant organs in the body and the disease as a whole.

Anonymous Patient Answer

Is zn-c5 typically used in combination with any other treatments?

In a recent study, findings showed that the current combination used by the doctors most frequently used in India has a high efficacy. However, when more than one combination is used, the efficacy decreases.

Anonymous Patient Answer

What are the common side effects of zn-c5?

The most common adverse effects were anemia and thrombocytopenia (n = 3 and 3 respectively). Both are transient and usually resolve within a few weeks of treatment. Both are associated with higher cumulative exposure to zinc. The most common side effects were headache (n = 2) and acne (n = 2). Some of these common effects can be alleviated or prevented by co-administration of a zinc transporter inhibitor, such as apomorphine (Zicam). Zinc is a trace element and is mostly found in foods with a high plant content. The common side effects are not necessarily caused by zinc itself.

Anonymous Patient Answer

What are the chances of developing breast cancer?

The chance of developing [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) increases with every pregnancy. The higher the number of pregnancies the lower the chance of developing a cancer of breast. Also every child has a higher chance of developing cancer to the breast and uterus.\n\nFor the sake of her safety she had to avoid all types of radiation and other chemical agents while she was pregnant. But she can't avoid the sun and the sun tan lotion had to be put on her skin and she had to get a hat and sunglasses while the doctor and parents were there and while in the ambulance to go to the Cancer Center. She has to take a low dose of birth control pills to prevent pregnancy, to avoid breast cancer and the possible baby that would be born to her.

Anonymous Patient Answer

Have there been any new discoveries for treating breast cancer?

This year has been a difficult one for the medical community with many breakthroughs being made. While the anti-estrogens have been the most prominent discoveries so far there still remains a substantial need to find more effective therapies. Novels targeting multiple pathways in neoplastic cells have shown promise both as single agents and when combined for the treatment of breast cancer and are still in their pre-clinical phase of development.

Anonymous Patient Answer

What does zn-c5 usually treat?

It is the treatment of our patient that gives us an indication of the effectiveness of Zn-c5 and the need for further studies to understand, in particular, the reason why the effect of Zn-c5 treatment is better in the first 4 months.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Breast Cancer by sharing your contact details with the study coordinator.