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All Drugs and Chemicals

Antineoplastic Agents

Androgens

Fluorouracil

Belinostat

Parathyroid Hormone

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Histone Deacetylase Inhibitors

Enzyme Inhibitors

300, 600, or 1000 mg/m2 belinostat IV for 5 days every 21 days starting with cycle 1

belinostat

250, 500, 750, or 1000 mg/m2/d of 5-FU starting with cycle 2 onwards in combination with belinostat. Starting on day 2, 5-FU is administered as a continuous 96 hour infusion.

5-Fluorouracil (5-FU)

Topotarget A/S

This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).

Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors

A Phase I Safety, Pharmacodynamic, Anti-Tumor Activity, and Pharmacokinetic Study of PXD101 Alone and in Combination With 5-Fluorouracil in Patients With Advanced Solid Tumors

Valerio Therapeutics

Recurrence

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Phyllodes Tumor of the Breast

Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.

Adjuvant Radiotherapy

Richard J. Barth, MD

PURPOSE: This phase II trial studied how well radiation therapy works after surgery in treating women with phyllodes tumor of the breast.

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy following surgery may be effective in treating patients with phyllodes tumor of the breast.

OBJECTIVES:

* Determine the local recurrence rate in women with phyllodes tumors of the breast previously treated with local excision with negative margins and are now treated with adjuvant radiotherapy.
* Determine the survival rate in patients treated with this regimen.

METHODS: Within 12 weeks after prior local excision or breast reexcision, patients underwent adjuvant radiotherapy 5 days a week for a total of 28 treatments. Patients were then followed every 6 months for 10 years.

Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast

A Prospective Study of Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors

Local recurrence rate of phyllodes tumors

Survival will be tracked for 10 years after initial resection of first participant treated.

National Cancer Institute (NCI)

Dartmouth-Hitchcock Medical Center

Chief, Section of General Surgery

Adjuvant radiation after local excision or breast re-excision.

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Richard J. Barth Jr., MD

Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.

Adjuvant Radiotherapy: Adjuvant radiation therapy

Local Recurrence Rate

All patients received adjuvant radiotherapy as specified in the protocol. No patients were lost to follow-up. Duration of follow-up ranged from 12 to 129 months, with a median follow-up of 56 months and a mean follow-up of 60 months. Ninety percent of the patients were followed for at least 2 years.

Survival Rate

Overall Study

Radiation therapy will be administered in the vicinity of the center where the surgical resection was performed. Adjuvant radiation must start within 12 weeks of breast excision or re-excision. The radiation oncologist can choose between two methods of partial breast irradiation (PBI): external beam partial breast radiation or Mammosite® brachytherapy, based on radiation oncologist and patient preference. Radiation will be administered per guidelines used in the NSABP B-39/RTOG 0413 protocol.

Partial breast radiation after lumpectomy

Richard J Barth, JR, MD

In 2008 a research study conducted by Dr. Barth involving 46 women determined that whole breast radiation therapy performed after a lumpectomy of borderline and malignant phyllodes tumors decreases rate of recurrence. None of the 46 participants developed a local recurrence.

Based on information we have learned from research studies, we recommend whole breast radiation therapy for women with malignant and borderline phyllodes tumors after they receive a lumpectomy.

New methods for delivering breast radiotherapy are being developed that allow radiation to be delivered solely to the site of the surgical resection. This is called partial breast radiation. The main advantage of partial breast radiation is that it simplifies treatment for the patient. Radiation is delivered twice a day for 5 days, rather than 5 days per week for 6 weeks. The main concern is that partial breast radiation might miss other sites of breast cancer in the breast receiving the radiation.

Evidence is accumulating from research studies that partial breast radiation therapy after surgical removal of the more common type of breast cancer, invasive ductal carcinoma, the breast results in rates of local recurrence that are comparable to those seen after whole breast radiation therapy.

In contrast to patients with invasive ductal cancers of the breast, it is very rare for patients to have phyllodes tumors that appear in more than one area of the breast. Review of research data determined that cancer recurrences seen in patients with phyllodes tumors that had undergone lumpectomies were almost always at the original tumor site. Therefore, partial breast radiation is likely to be as effective as whole breast radiation therapy after resection of malignant phyllodes tumors.

The purpose of the study is to determine what the chances are that a phyllodes tumor will recur in the breast when the breast is treated with partial breast radiation therapy after a lumpectomy.

Phyllodes Tumor Partial Breast Radiation Study

A Prospective Study of Partial Breast Adjuvant Radiation Therapy After Resection of Borderline and Malignant Phyllodes Tumors

The primary objective is to determine the local recurrence rate for patients with borderline or malignant phyllodes tumors treated with breast conserving resection with negative margins and adjuvant partial breast radiation therapy. Recurrence rate is measured by occurrence of biopsy proven recurrences during follow up, up to 10 years following patient enrollment.

The secondary objective is to compare the local recurrence rate observed after partial breast radiation therapy with that observed in historical controls treated with whole breast radiation therapy after breast conserving resection with negative margins. This is measured by occurrence of biopsy proven recurrence up to 10 years after participant enrollment.

These physical exams should occur every 6 months (+/- 3 months) after the initial resection through year 5 ( ie. at 6,12,18,24,30,36,42,48,54,and 60 months) and then every 12 months (+/- 3 months) years 5 through 10 (ie. 72, 84, 96,108 and 120 months). Information relating to adverse events and serious adverse events for the historical controls can be found under NCT00003404.

Radiation per NSABP B-39/R0413 protocol.

Partial breast radiation after lumpectomy: Radiation therapy will be administered in the vicinity of the center where the surgical resection was performed. Adjuvant radiation must start within 12 weeks of breast excision or re-excision. The radiation oncologist can choose between two methods of partial breast irradiation (PBI): external beam partial breast radiation or Mammosite® brachytherapy, based on radiation oncologist and patient preference. Radiation will be administered per guidelines used in the NSABP B-39/RTOG 0413 protocol.

Partial Breast Radiation After Lumpectomy

Historical controls treated with whole breast radiation therapy after breast conserving resection with negative margins

Historical Control

Total

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Richard Barth

The following participants did not complete 10 years of follow up and were followed until the time points listed below:

1. participant lost to follow up after 6 months
2. participants lost to follow up after 1 year

1 participant withdrew after 9 years 6 participants remained on study until early study closure they were at the following time points at closure: 2 participants 4.5 years

1 participant 5 years

1 participant 6 years

1 participant 8 years

1 participant 9 years

Rate of Participants With Local Recurrence up to 10 Years

Historical controls treated with whole breast radiation therapy after breast conserving resection with negative margins.

Historical Controls

The following participants did not complete 10 years of follow up and were followed until the time points listed below:

1. participant lost to follow up after 6 months
2. participants lost to follow up after 1 year

1 participant withdrew after 9 years 6 participants remained on study until early study closure they were at the following time points at closure 2 participants 4.5 years

1 participant 5 years

1 participant 6 years

1 participant 8 years

1 participant 9 years

Rate of Participants With Local Recurrence After Radiation Compared to Historic Controls

Historical controls treated with whole breast radiation therapy after breast conserving resection with negative margins. Information regarding the historical controls can be found under NCT00003404.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors	NCT00413322	Tumor	belinostat 5-Fluorouracil ...	18 Years -	Valerio Therapeutics
Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast	NCT00003404	Breast Cancer	Adjuvant Radiot...	18 Years - 120 Years	Dartmouth-Hitchcock Medical Center
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors	NCT00413322	Tumor	belinostat 5-Fluorouracil ...	18 Years -	Valerio Therapeutics
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors	NCT00413322	Tumor	belinostat 5-Fluorouracil ...	18 Years -	Valerio Therapeutics
Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast	NCT00003404	Breast Cancer	Adjuvant Radiot...	18 Years - 120 Years	Dartmouth-Hitchcock Medical Center
Phyllodes Tumor Partial Breast Radiation Study	NCT01089374	Phyllodes Tumor	Partial breast ...	18 Years -	Dartmouth-Hitchcock Medical Center
Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast	NCT00003404	Breast Cancer	Adjuvant Radiot...	18 Years - 120 Years	Dartmouth-Hitchcock Medical Center

Spots Global Cancer Trial Database for phyllodes tumor