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TRIal evalUating the Menstrual and Ovarian Function of Young Breast Cancer Patients Treated With a cycloPHosphamide-free Regimen (TRIUMPH)

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ClinicalTrials.gov Identifier: NCT02053597
Recruitment Status : Withdrawn (due to evolving scientific knowledge in the field that would make the questions being addressed in the trial less relevant)
First Posted : February 3, 2014
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute

Brief Summary:
Recently, there has been a rising trend of delaying childbearing and hence more women are diagnosed with breast cancer before completing their families. Given the continuous decline in recurrences and death secondary to breast cancer and the reassuring data on the safety of pregnancy following breast cancer more women are inquiring into the possibility of preserving fertility following chemotherapy. The challenge remains in using a regimen that is devoid of cyclophosphamide, but is as effective as the standard regimens that incorporate cyclophosphamide. The combination doxorubicin (50 mg/m2) and paclitaxel (200 mg/m2) (AP) followed by 12 weeks of paclitaxel (80 mg/m2) (P) emerges as a treatment option with convincing results regarding its effectiveness in the early setting, and could be potentially associated with less ovarian toxicity being devoid of cyclophosphamide.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Doxorubicin Drug: paclitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II TRIal evalUating the Menstrual and Ovarian Function of Young Breast Cancer Patients Treated With a cycloPHosphamide-free Regimen Composed of Doxorubicin and Paclitaxel
Study Start Date : October 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: doxorubicin and paclitaxel
All patients will receive four cycles of doxorubicin (A) (50 mg/m2) and paclitaxel (P) (200 mg/m2), given on a three-weekly basis for four cycles, followed by weekly paclitaxel (P) (80 mg/m2) for twelve weeks.
Drug: Doxorubicin
All patients will receive four cycles of doxorubicin (A) (50 mg/m2)

Drug: paclitaxel
All patients will receive four cycles paclitaxel (P) (200 mg/m2), given on a three-weekly basis for four cycles, followed by weekly paclitaxel (P) (80 mg/m2) for twelve weeks.




Primary Outcome Measures :
  1. Change from baseline in ovarian function [ Time Frame: At screening, after 4 cycles of chemotherapy, at the end of chemotherapy, at 6, 12, 18 and 24 months following chemotherapy ]

    Ovarian function will be evaluated using serum FSH, estradiol and AMH. Ovarian failure is defined as serum FSH >40 IU/L. Ovarian insufficiency is defined as serum FSH level from 20 - 40 IU/L. Ovarian reserve will be evaluated by serum AMH. Adequate ovarian reserve is defined as serum AMH >1 ng/ml. Menstrual function will be evaluated by collecting information of the 1st day of last menstrual cycle, and cycle length (days between two menstruating periods).

    Ovarian function will be evaluated using serum FSH, estradiol and AMH. Ovarian failure is defined as serum FSH >40 IU/L. Ovarian insufficiency is defined as serum FSH level from 20 - 40 IU/L. Ovarian reserve will be evaluated by serum AMH. Adequate ovarian reserve is defined as serum AMH >1 ng/ml.


  2. Change from baseline in menstrual function [ Time Frame: At screening, after 4 cycles of chemotherapy, at the end of chemotherapy, at 6, 12, 18 and 24 months following chemotherapy ]
    Menstrual function will be evaluated by collecting information of the 1st day of last menstrual cycle, and cycle length (days between two menstruating periods). In patients menstruating regularly after 12 months of chemotherapy cessation, information on menstrual cycle will be collected at 6-monthly intervals until developing menopause, disease recurrence, becoming pregnant, whichever occurs earlier, for a maximum period of 5 years after end of chemotherapy.


Secondary Outcome Measures :
  1. Ovarian reserve [ Time Frame: At 12 months following the end of chemotherapy. ]
    A serum AMH determination will be performed at 12 months after the end of chemotherapy. An adequate ovarian reserve is defined as serum AMH >1 ng/ml at that timepoint.

  2. Occurence of Adverse Events [ Time Frame: From the signature of informed consent until until the end of study treatment/treatment discontinuation visit 30 days after the last dose of study medication ]
    This study will use the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0, for adverse event reporting.

  3. Impact of treatment on the behavior of menstruation after menses resumption [ Time Frame: At 18, 24 and 60 months after end of chemotherapy. ]
    In patients menstruating regularly after 12 months of chemotherapy cessation, information on menstrual cycles will be collected at 18, 24 and up to 60 months after end of chemotherapy, until developing menopause, disease recurrence or becoming pregnant, whichever occurs earlier. This information will include the date of last menstrual period, menstruation duration and if 2 or more consecutive menstrual cycles were missed, allowing to assess irregularity and possible cessation of menses.

  4. Evaluate the impact of a cyclophosphamide-free regimen on sexual function [ Time Frame: At baseline, after 4 cycles, end of chemotherapy, 6, 12 and 24 months following the end of chemotherapy. ]
    Patient will complete two validated health-related quality of life questionnaires, one on menopausal symptoms (FACT-ES version 4) and the other on sexual functioning (FSAQ).

  5. Evaluate the impact of the regimen on peripheral neurotoxicity [ Time Frame: At baseline, after 4 cycles, end of chemotherapy, 6, 12 and 24 months following the end of chemotherapy. ]
    Patient will complete one validated health-related quality of life questionnaire on peripheral neurotoxicity (FACT-Taxane version 4).

  6. Pregnancy rate after cessation of chemotherapy [ Time Frame: From end of chemotherapy up until 60 months after. ]
    Number of pregnancies among participants.

  7. Event-free survival [ Time Frame: From the date of registration up until 60 months after the end of chemotherapy. ]
    Event-free survival will be calculated from the date of registration to the study to developing local, loco-regional or distant metastasis, secondary malignancies or death. All patients will be considered for the primary efficacy analysis (ITT analysis).



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≤ 40 years.
  2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  3. Non-metastatic primary invasive carcinoma of the breast eligible for adjuvant or neoadjuvant chemotherapy.
  4. Negative estrogen (ER) and progesterone receptor (PgR) status.
  5. Baseline left ventricular ejection fraction (LVEF) ≥50% measured by an echocardiogram or MUGA.
  6. Interested in maintaining menstrual and/or ovarian function following completion of chemotherapy.
  7. Known HER2/neu status.
  8. Negative pregnancy test within 14 days prior to starting chemotherapy.
  9. Adequate hematologic, hepatic and renal function.
  10. Signed informed consent.

Exclusion Criteria:

  1. History of prior malignant disease (breast or non-breast) or non-malignant condition which was treated with chemotherapy, pelvic irradiation or any therapy that could potentially affect ovarian function.
  2. Previous history of amenorrhea > 3 months within the last 2 years (excluding pregnancy).
  3. Ovarian insufficiency defined as serum FSH > 20 IU/L at the local laboratory, anytime during the menstrual cycle.
  4. Any ovarian pathology or abnormalities at the screening pelvic ultrasound, except for functional follicular cysts.
  5. Pregnant or breastfeeding patients.
  6. Inability or unwillingness to use effective contraception during and up to 3 months after the last dose of study medication. Effective methods include the following: non-hormonal intrauterine device, barrier method - condoms, diaphragm - also in conjugation with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not allowed.
  7. Concurrent use of any other cytotoxic or hormonal agent, namely GnRH agonists.
  8. Prior pre-existing peripheral neuropathy of any cause, including diabetes mellitus, alcohol abuse, HIV infection, autoimmune and hereditary neuropathies, amyloidosis, hypothyroidism, vitamin deficiencies.
  9. Serious cardiac illness, uncontrolled hypertension or medical condition that would affect administration of chemotherapy and compliance to study procedures.
  10. Known sensitivity to any of the study medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053597


Locations
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Belgium
GZA Ziekenhuisen Campus Sint-Augustinus - Iridium Kankernetwerk
Antwerp, Wilrijk, Belgium, 2610
Jules Bordet Institute
Brussels, Belgium, 1000
Hôpital Erasme
Brussels, Belgium, 1070
Clinique et Maternité Sainte Elisabeth
Namur, Belgium, 5000
Sponsors and Collaborators
Jules Bordet Institute
Investigators
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Principal Investigator: Daphné Tkint de Roodenbeke, MD, PhD Jules Bordet Institute
Principal Investigator: Hatem Azim, MD, PhD Jules Bordet Institute
Principal Investigator: Isabelle Demeestere, MD, PhD Hôpital Erasme
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Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT02053597    
Other Study ID Numbers: CE2142
2013-000173-77 ( EudraCT Number )
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015
Keywords provided by Jules Bordet Institute:
Primary breast cancer
Young women
Ovarian function
Sexual function
Eligible for adjuvant or neoadjuvant chemotherapy
Negative hormone-receptor status
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors