Palbociclib PD-0332991 for Breast Cancer

Phase-Based Estimates
2
Effectiveness
3
Safety
Contact: German Breast Group, Neu-Isenburg, Germany
Breast Cancer+5 More
Palbociclib PD-0332991 - Drug
Eligibility
18+
Female
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether a drug called palbociclib can improve survival in women with breast cancer.

See full description

Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms
  • Hormonreceptor Positive
  • CPS-EG Score
  • Postneoadjuvant Treatment With CDK 4/6 Inhibitor
  • Her2normal

Treatment Effectiveness

Effectiveness Estimate

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

Study Objectives

This trial is evaluating whether Palbociclib PD-0332991 will improve 1 primary outcome, 9 secondary outcomes, and 1 other outcome in patients with Breast Cancer. Measurement will happen over the course of Pharmacokinetic Outcomes Measure mit Cmax and AUC.

2019 and with interim analysis on safety
compliance and safety according to NCI-CTCAE Version 4.0
Month 71
quality-adjusted life years (QALY), health economic outcomes EQ-5D
Month 71
patients reported outcomes EORTC QLQ C30, • EORTC QLQ BR-23, • EORTC QLQ FA-13 Fatigue, • GAD7 patient self-rating mood scale
Pharmacokinetic Outcomes Measure mit Cmax and AUC
correlations between exposure and efficacy and/or safety findings
Month 71
distant disease free survival (DDFS)
iDFS excluding second non-breast cancers
iDFS per treatment group in patients with luminal-B tumors (as determined by e.g. PAM50 or any other commercially available test at the time of analysis)
Month 71
overall survival (OS)
Time-to-Event Outcome measure. Final analysis on the primary endpoint and secondary efficacy endpoints (except for OS) Analysis will be conducted when 255 events observed. Assessed until approx. Dec 2020.
Invasive disease free survival (iDFS) for palbociclib vs. placebo in patients with high CPS-EG score after neoadjuvant chemotherapy receiving standard adjuvant endocrine therapy for HR-positive/HER2-normal primary breast cancer.
pre and posttherapy up to 13months
Scores and markers for their prognostic value in this specific trial setting and their predictive information on the efficacy and/or safety of palbociclib
Hour 24
Area under the Curve (AUC), Cmax

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Placebo
Palbociclib
Placebo group

This trial requires 1250 total participants across 2 different treatment groups

This trial involves 2 different treatments. Palbociclib PD-0332991 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.

Palbociclib
Drug
Palbociclib at a dose of 125 mg once daily, day 1 to day 21 followed by 7 days off treatment in a 28-day cycle for thirteen cycles
Placebo
Drug
Placebo of palbociclib once daily day 1 to day 21 followed by 7 days off treatment in a28-day cycle for thirteen cycles

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change outcome up to 71 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change outcome up to 71 months for reporting.

Closest Location

NSABP Foundation - Pittsburgh, PA

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Breast Cancer or one of the other 5 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Based on protocol G version 11 dated 04 May 2017
Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
Residual invasive disease post-neoadjuvant either in the breast or as residual nodal invasion.
Willingness and ability to provide archived formalin fixed paraffin embedded tissue block or a partial block from surgery after neoadjuvant chemotherapy and from core-biopsy before start of neoadjuvant chemotherapy, which will be used for centralized retrospective confirmation of hormone- and HER2-status and to evaluate correlation between genes, proteins, and mRNAs relevant to the endocrine and cell cycle pathways and sensitivity/resistance to the investigational agents. In case of bilateral breast cancer, tumor tissue of both sides needs to be assessable.
Histologically confirmed unilateral or bilateral primary invasive carcinoma of the breast.
Centrally confirmed hormone-receptor-positive (≥1% ER and/or PR positive stained cells) and HER2-normal (IHC score 0-1 or FISH negative (in-situ hybridization (ISH) ratio) <2.0 status) assessed preferably on tissue from post-neoadjuvant residual invasive disease or core biopsy of the breast, or if no other tissue is available the residual tumor of the lymphnode can be assessed.
In case of bilateral breast cancer hormonreceptor positivity and HER2-normal status has to be centrally confirmed for both sides.
Centrally assessed Ki-67, pRB, and Cyclin D1 status assessed preferably on post-neoadjuvant residual invasive disease of the breast, or if not possible, of residual nodal invasion or core biopsy. In case of bilateral breast cancer, tumor tissue of both sides needs to be assessable.
Patients must have received neoadjuvant chemotherapy of at least 16 weeks. This period must include 6 weeks of a taxane -containing neoadjuvant therapy (Exception: For patients with progressive disease that occurred after at least 6 weeks of taxane-containing neoadjuvant treatment, a total treatment period of less than 16 weeks is also eligible).
Adequate surgical treatment including resection of all clinically evident disease and ipsilateral axillary lymph node dissection. Histologically complete resection (R0) of the invasive and ductal in situ tumor is required in case of breast conserving surgery as the final treatment. No evidence of gross residual disease (R2) is required after total mastectomy (R1 resection is acceptable). Axillary dissection is not required in patients with a negative sentinel-node biopsy before (pN0, pN+(mic)) or after (ypN0, ypN+(mic) neoadjuvant chemotherapy.

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 causes breast cancer?

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There is no single underlying cause for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), although some studies hint at a possible genetic relationship to breast cancer risk. The incidence of breast cancer in people who have not had a first-degree relative with cancer (sibs, grandparents or younger siblings) is around half that of people with a first-degree relative who has the disease. For those with a first-degree relative who has the disease, it is as much as 8 times higher. This may be because people who are first-degree relatives of people who have breast cancer are more likely to have a family history of the disease, and in families where the disease is hereditary, a higher proportion of cases in the family are due to hereditary factors as opposed to environmental risk factors.

Unverified Answer

What are common treatments for breast cancer?

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Breast cancer surgery is the best treatment to date, followed by chemotherapy. Radiation therapy and targeted therapy are becoming popular in the UK. Chemotherapy is the best treatment for some subtypes of this disease. The use of targeted therapies and radiation therapy, however, remain controversial. At present, the treatments used are largely based on the type of cancer with its characteristics.

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What are the signs of breast cancer?

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In a recent study, findings has shown a high level of awareness and high index of suspicion of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in the general population even in a small city like Kota in this part of Asia. Breast imaging is recommended only after thorough history taking and examination but a larger study is needed to confirm these results.

Unverified Answer

Can breast cancer be cured?

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Patients with early-stage breast cancer who achieve a remission after neoadjuvant chemotherapy and mastectomy can expect to live for 10 years or more without further treatment.

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What is breast cancer?

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Breast cancer is a disease that forms in the parenchyma of the tissues surrounding the breast. A number of benign disorders can cause breast enlargement or pain. This article describes breast cancer in general and why you should be aware of breast cancer, and specific types and how you should manage them, such as when mastectomy is the preferred treatment.

Unverified Answer

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

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In 2006, 1 in 7 women and 1 in 39 men ages 20-59 years had breast cancer diagnosed at least once in the past 12 months. Breast cancer deaths increased more than 2-fold from 1991 to 2006. The higher incidence of breast cancer among women may be the result of more aggressive screening efforts for breast cancer since the 1950s. In 2006, about 20% of breast cancer cases were diagnosed before the age of 20. A significant number of women, especially those over the age of 80 are diagnosed with the disease, but many of these women do not receive treatment.

Unverified Answer

Have there been other clinical trials involving palbociclib pd-0332991?

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Palbociclib is an active second-line treatment for metastatic hormone receptor-positive, HER2-negative, unresectable/incurable disease in patients with advanced, locally advanced or metastatic, pre-treated, HER2/neu+/c-kit+/hsp90 wild or resistant (as determined by a bona-fide biomarker assay) disease. Palbociclib may reduce disease progression in patients with the above disease, as well as in patients with locally advanced and untreated unresectable/c-kit-/hsp90 ligand dependent disease. Palbociclib is well tolerated.

Unverified Answer

How does palbociclib pd-0332991 work?

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Palbociclib is an anti-proliferative agent used to treat hormone receptor negative [metastatic breast cancer](https://www.withpower.com/clinical-trials/metastatic-breast-cancer). This first-in-class compound is a potent inhibitor of mammalian target of rapamycin (mTOR) with similar potency to rapamycin but does not interfere with the function of mammalian target of rapamycin 1 (mTORC1). Targeting mTORC1 with palbociclib might prevent ER+ breast cancer progression.

Unverified Answer

Who should consider clinical trials for breast cancer?

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In this contemporary era, randomized studies of adjuvant therapies showed no difference in OS or DFS between conservatively and aggressively treated groups. In the absence of randomized studies evaluating the relative efficacy of aggressive chemo- and radiation-based treatment, these options are not acceptable. On the contrary, in a large retrospective analysis of 3,097 patients, the addition of either post-operative radiation therapy or chemotherapy to surgery was associated with significantly improved OS. This reinforces the view that these protocols represent sensible clinical trial designs.

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How quickly does breast cancer spread?

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The majority of patients developed clinically detectable disease within a 3-5-month window, consistent with the average clinical course for newly diagnosed breast cancer with Stage II and a wide fraction of pT1 patients, which may reflect a biologically distinct biological profile. We should be cautious interpreting the results of studies using long-term survival data to guide patient counseling.

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What is the primary cause of breast cancer?

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The increase in [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) incidence is due to the increase in female body mass. Over this period of time, female bodies are gaining weight; in the U.S. the average weight in 2000 was about 25 years after the start of the study. It is more common in developed (U.S.) countries, where it is not unusual for 70 percent or more of adult women to be overweight. When a woman is obese, she has almost no chance of avoiding breast cancer, the greatest proportion of cancers being in the women's breasts and around the aorta and subclavian arteries.

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What is palbociclib pd-0332991?

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Palbociclib pd-0332991 is efficacious and well tolerated in patients with advanced basal-like or HER2/neu-overexpressing breast cancers.  A manageable and effective next-line therapy for these patients is likely to be clinically advantageous with the potential for clinical relevance because it is not based on targeted EGFR or ERBB2 signaling.  Palbociclib pd-0332991 is a promising therapy for patients with advanced basal-like and HER2/neu-overexpressing breast cancers who have received two or more previous systemic therapy regimens.

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